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Immune checkpoint inhibitors (ICI) have significantly improved overall survival in melanoma patients. However, 60% experience severe adverse events and early response markers are lacking. Circulating tumour DNA (ctDNA) is a promising biomarker for treatment-response and recurrence detection. The prospective PET/LIT study included 104 patients with palliative combined or adjuvant ICI. Tumour-informed sequencing panels to monitor 30 patient-specific variants were designed and 321 liquid biopsies of 87 patients sequenced. Mean sequencing depth after deduplication using UMIs was 6000x and the error rate of UMI-corrected reads was 2.47×10 -4 . Variant allele fractions correlated with PET/CT MTV (rho=0.69), S100 (rho=0.72), and LDH (rho=0.54). A decrease of allele fractions between T1 and T2 was associated with improved PFS and OS in the palliative cohort (p = 0.008 and p < 0.001). ctDNA was detected in 76.9% of adjuvant patients with relapse (n = 10/13), while all patients without progression (n = 9) remained ctDNA negative. Tumour-informed liquid biopsies are a reliable tool for monitoring treatment response and early relapse in melanoma patients with ICI., (© 2024. The Author(s).)

Objectives: The purpose of this study was to investigate the imaging characteristics of medication-related osteonecrosis of the jaw (MRONJ) using [18F]fluoride positron emission tomography/computed tomography (PET/CT) and [18F]fluorodeoxyglucose (FDG) PET/magnetic resonance imaging (MRI) for preoperative assessment and to correlate them with microarchitectural and histomorphometric data with respect to clinical findings., Methods: Twelve patients (five female; mean age 75 ± 7.6 yr) with symptomatic MRONJ underwent both scans on the same day, and imaging findings were used to plan surgical interventions for seven patients. Bone tracer uptake was classified as high, medium, or low, and surgical samples were evaluated using Micro-CT and histomorphometric analysis., Results: CT showed medullary sclerosis in all patients, and MRI revealed gadolinium enhancement in four patients. PET imaging revealed remarkably elevated [18F]fluoride uptake and moderately increased [18F]FDG uptake in MRONJ compared to healthy jawbones, with both differences being statistically significant. [18F]fluoride uptake was associated with necrosis, bacteria, and inflammatory tissue. Micro-CT data did not show significant differences, but histomorphometric analysis revealed higher osteocyte and lacunae densities in the high [18F]fluoride uptake group, and more necrotic bone in the medium [18F]fluoride uptake group. Bacteria were observed in all areas., Conclusions: In summary, [18F]fluoride PET accurately identified MRONJ extent, revealing functional changes in jawbone remodeling not visible on CT. [18F]FDG PET showed differences in bone and soft tissue, though less pronounced. This method aids in evaluating disease activity and guiding treatment planning, requiring further research for optimal surgical approaches based on tracer uptake.

Purpose: To investigate the impact of [ 18 F]FDG-PET/CT on the management of differentiated thyroid carcinoma (DTC) in routine clinical settings., Material and Methods: In total, 98 patients (55 females, age 56 ± 18 years) with histologically confirmed thyroid cancer, including all types of DTC and poorly differentiated thyroid cancer (PDTC, n = 7), underwent [ 18 F]FDG-PET/CT for staging or recurrence diagnostics performed using a state-of-the art clinical scanner (Biograph mCT, Siemens Healthineers) with a standardized examination protocol. The impact of PET/CT on clinical decision making was prospectively evaluated using standardized questionnaires completed by the referring physicians before and after PET/CT. Patient outcome was analyzed for OS drawn from patient records., Results: Referring physicians were unable to establish a treatment plan for 81% of patients with thyroid cancer in the absence of PET/CT. The use of PET/CT had a notable influence on patient management, leading to the development of a well-defined treatment plan for 92% of patients. Moreover, after PET/CT a change in pre-PET/CT-intended treatments occurred in 32% of cases, and further invasive diagnostic could be waived in 7% of cases. [ 18 F]FDG-PET/CT revealed a tumor detection rate of 68% (local tumor: 19%, lymph node metastases: 40%, distant metastases: 42%). HTg levels, when stimulated via TSH, were considerably higher in patients with metastases detected on PET/CT, compared to those without metastatic findings ( p = 0.02). OS was significantly worse in patients with PDTC ( p = 0.002) compared to follicular thyroid cancer (FTC) and PTC or even in patients with distant metastases at first diagnosis ( p = 0.03)., Conclusions: This prospective registry study confirms that [ 18 F]FDG-PET/CT used in a routine clinical setting has a very important impact on the management of patients with thyroid cancer by initiating treatments and reducing the uses of additional imaging and invasive tests.

Actinic keratosis (AK) are common lesions in light-skinned individuals that can potentially progress to cutaneous squamous cell carcinoma (cSCC). Both conditions may be associated with significant morbidity and constitute a major disease burden, especially among the elderly. To establish an evidence-based framework for clinical decision making, the guideline "actinic keratosis and cutaneous squamous cell carcinoma" was updated and expanded by the topics cutaneous squamous cell carcinoma in situ (Bowen's disease) and actinic cheilitis. The guideline is aimed at dermatologists, general practitioners, ear nose and throat specialists, surgeons, oncologists, radiologists and radiation oncologists in hospitals and office-based settings, as well as other medical specialties, policy makers and insurance funds involved in the diagnosis and treatment of patients with AK and cSCC. A separate guideline exists for patients and their relatives. In this part, we will address aspects relating to epidemiology and etiology, diagnostics, surgical and systemic treatment of cutaneous squamous cell carcinoma (cSCC), surveillance and prevention., (© 2023 The Authors. Journal der Deutschen Dermatologischen Gesellschaft published by Wiley-VCH GmbH on behalf of Deutsche Dermatologische Gesellschaft.)

There is a lack of evidence regarding the clinical impact of [ 18 F]fluorodeoxyglucose positron emission tomography/computed tomography ([ 18 F]FDG-PET/CT, hereinafter referred to as PET/CT), especially regarding management changes and their link to overall survival. We analyzed 52 PET/CTs in 47 stage I-IV breast cancer patients, selected from a prospective oncological PET/CT registry. Indications for PET/CT were primary staging ( n = 15), restaging ( n = 17), and suspected recurrence ( n = 20). PET/CT-induced management changes were categorized as major or minor. PET/CT-induced management changes in 41 of 52 scans (78.8%; 38 of 47 patients (80.9%)), of which major changes were suggested in 18 of 52 scans (34.6%, 17 of 47 patients, 36.2%). PET/CT downstaged 6 of 15 primary staging patients, excluding distant metastases. Major management changes were documented in 3 of 17 restaging exams. PET/CT ruled out clinically suspected recurrence in 6 of 20 cases and confirmed it in 11 of 20. In three cases, locoregional recurrence had already been diagnosed via biopsy. In 30 of 52 exams, additional diagnostic tests were avoided, of which 13 were invasive. PET/CT-based management changes resulted in a 5-year survival rate of 72.3% for the whole study group, 93.3% for the staging group, 53.8% for the restaging group, and 68.4% for the recurrence group. This study shows that PET/CT significantly impacts clinical management decisions in breast cancer patients in different clinical scenarios, potentially determining the patient's tumor stage as the basis for further therapy more reliably and by avoiding unnecessary diagnostic tests.

Objective: The aim of this study was to evaluate the impact of PET/CT on clinical management of patients with germ cell tumors (GCTs) conducted in a real-world setting, including avoidance of invasive procedures, additional diagnostic imaging, and changes in treatment., Methods: Patients with GCTs were prospectively enrolled into a PET/CT registry study between May 2013 and April 2021. Intended patient management prior and after PET/CT was documented using standardized questionnaires. Changes in oncologic staging and clinical management after PET/CT were recorded, including planned treatment and planned additional diagnostics., Results: Forty-three male patients with GCTs were included consecutively in this study. After PET/CT, oncologic staging changed in 22/43 patients (51%), with upstaging in seven cases (16%), downstaging in ten cases (23%), and cancer relapse in five cases (11%). The number of patients with intended curative treatment remained stable, while a considerable change in intended therapeutic intervention was noted after PET/CT, with an increase in planned chemotherapy from three to eleven patients and a decrease in planned surgical resection from eleven to two patients. In addition, PET/CT contributed to preventing patients from intended invasive procedures including biopsy and surgery in 8/43 (19%) cases and from additional diagnostic procedures in 25 (58%) cases., Conclusion: With the use of FDG-PET/CT as a tool to guide patient management in GCTs, we observed a notable impact on clinical staging and a consequent reduction in the need for additional invasive and diagnostic procedures. These findings are expected to be even more consequential in the future as treatment modalities improve and the life expectancy of GCT patients further increases., Key Points: PET/CT considerably influences the clinical stage of GCT patients. PET/CT has remarkable influence on the choice of therapeutic interventions and reduces additional diagnostic procedures.

We describe a publicly available dataset of annotated Positron Emission Tomography/Computed Tomography (PET/CT) studies. 1014 whole body Fluorodeoxyglucose (FDG)-PET/CT datasets (501 studies of patients with malignant lymphoma, melanoma and non small cell lung cancer (NSCLC) and 513 studies without PET-positive malignant lesions (negative controls)) acquired between 2014 and 2018 were included. All examinations were acquired on a single, state-of-the-art PET/CT scanner. The imaging protocol consisted of a whole-body FDG-PET acquisition and a corresponding diagnostic CT scan. All FDG-avid lesions identified as malignant based on the clinical PET/CT report were manually segmented on PET images in a slice-per-slice (3D) manner. We provide the anonymized original DICOM files of all studies as well as the corresponding DICOM segmentation masks. In addition, we provide scripts for image processing and conversion to different file formats (NIfTI, mha, hdf5). Primary diagnosis, age and sex are provided as non-imaging information. We demonstrate how this dataset can be used for deep learning-based automated analysis of PET/CT data and provide the trained deep learning model., (© 2022. The Author(s).)

Besides tremendous treatment success in advanced melanoma patients, the rapid development of oncologic treatment options comes with increasingly high costs and can cause severe life-threatening side effects. For this purpose, predictive baseline biomarkers are becoming increasingly important for risk stratification and personalized treatment planning. Thus, the aim of this pilot study was the development of a prognostic tool for the risk stratification of the treatment response and mortality based on PET/MRI and PET/CT, including a convolutional neural network (CNN) for metastasized-melanoma patients before systemic-treatment initiation. The evaluation was based on 37 patients (19 f, 62 ± 13 y/o) with unresectable metastasized melanomas who underwent whole-body 18F-FDG PET/MRI and PET/CT scans on the same day before the initiation of therapy with checkpoint inhibitors and/or BRAF/MEK inhibitors. The overall survival (OS), therapy response, metastatically involved organs, number of lesions, total lesion glycolysis, total metabolic tumor volume (TMTV), peak standardized uptake value (SULpeak), diameter (Dmlesion) and mean apparent diffusion coefficient (ADCmean) were assessed. For each marker, a Kaplan−Meier analysis and the statistical significance (Wilcoxon test, paired t-test and Bonferroni correction) were assessed. Patients were divided into high- and low-risk groups depending on the OS and treatment response. The CNN segmentation and prediction utilized multimodality imaging data for a complementary in-depth risk analysis per patient. The following parameters correlated with longer OS: a TMTV < 50 mL; no metastases in the brain, bone, liver, spleen or pleura; ≤4 affected organ regions; no metastases; a Dmlesion > 37 mm or SULpeak < 1.3; a range of the ADCmean < 600 mm2/s. However, none of the parameters correlated significantly with the stratification of the patients into the high- or low-risk groups. For the CNN, the sensitivity, specificity, PPV and accuracy were 92%, 96%, 92% and 95%, respectively. Imaging biomarkers such as the metastatic involvement of specific organs, a high tumor burden, the presence of at least one large lesion or a high range of intermetastatic diffusivity were negative predictors for the OS, but the identification of high-risk patients was not feasible with the handcrafted parameters. In contrast, the proposed CNN supplied risk stratification with high specificity and sensitivity.

To investigate imaging features of osteomyelitis of the jaw (OMJ) using [18F]fluoride positron emission tomography (PET) and [18F]fluorodeoxyglucose (FDG)-PET compared with computed tomography (CT) and magnetic resonance imaging (MRI) to assess extent and disease activity. Six female patients (55.3 ± 10.0 years) were enrolled for assessment of symptomatic OMJ. 4/6 patients underwent [18F]FDG-PET/MRI and [18F]fluoride-PET/CT, one patient MRI and [18F]fluoride-PET/CT and another patient only [18F]FDG-PET/MRI. Image analysis was performed by two radiologists, an oral and maxillofacial surgeon, and a nuclear medicine specialist. The extent of affected jawbone was analyzed both qualitatively and quantitatively, including the PET tracer uptake, CT-Hounsfield-Units (HU) and MRI parameters in affected and healthy jawbone. All patients had trabecular sclerosis in the affected jawbone compared to healthy jawbone (560 ± 328 HU vs. 282 ± 211 HU; p > 0.05), while 3/6 patients had cortical erosions. Bone marrow edema and gadolinium enhancement were documented in 5/6 patients. In affected jawbone, [18F]fluoride-uptake was increased in all patients compared to healthy jawbone (SUVmean 15.4 ± 4.2 vs. 2.1 ± 0.6; p < 0.05), and [18F]FDG-uptake was moderately higher (SUVmean 1.9 ± 0.7 vs. 0.7 ± 0.2; p > 0.05). The extent of regions with increased metabolic activity was less than the extent of morphologic changes in all patients. Information on jawbone metabolism and inflammation is different from morphologic changes and therefore has the potential to provide a more accurate and objective assessment of the extent and activity of OMJ.

Background and Purpose: Tumor hypoxia is a major cause of resistance to radiochemotherapy in locally advanced head-and-neck cancer (LASCCHN). We present results of a randomized phase II trial on hypoxia dose escalation (DE) in LASCCHN based on dynamic [ 18 F]FMISO (dynFMISO) positron emission tomography (PET). The purpose was to confirm the prognostic value of hypoxia PET and assess feasibility, toxicity and efficacy of hypoxia-DE., Materials and Methods: Patients with LASCCHN underwent baseline dynFMISO PET/CT. Hypoxic volumes (HV) were derived from dynFMISO data. Patients with hypoxic tumors (HV > 0) were randomized into standard radiotherapy (ST: 70Gy/35fx) or dose escalation (DE: 77Gy/35fx) to the HV. Patients with non-hypoxic tumors were treated with ST. After a minimum follow-up of 2 years feasibility, acute/late toxicity and local control (LC) were analyzed., Results: The study was closed prematurely due to slow accrual. Between 2009 and 2017, 53 patients were enrolled, 39 (74%) had hypoxic tumors and were randomized into ST or DE. For non-hypoxic patients, 100% 5-year LC was observed compared to 74% in patients with hypoxic tumors (p = 0.039). The difference in 5-year LC between DE (16/19) and ST (10/17) was 25%, p = 0.150. No relevant differences related to acute and late toxicities between the groups were observed., Conclusion: This study confirmed the prognostic value of hypoxia PET in LASCCHN for LC. Outcome after hypoxia DE appears promising and may support the concept of DE. Slow accrual and premature closure may partly be due to a high complexity of the study setup which needs to be considered for future multicenter trials., Competing Interests: Conflicts of interest SW, FP, DZ and DT report institutional collaborations with Elekta, Philips, Dr. Sennewald, TheraPanacea and PTW Freiburg outside this study., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Detection of pulmonary nodules in MRI requires fast imaging strategies without respiratory motion impairment, such as single-breath-hold Cartesian VIBE. As patients with pulmonary diseases have limited breath-hold capacities, this study investigates the clinical feasibility of non-Cartesian Spiral VIBE under free-breathing compared to CT as the gold standard., Methods: Prospective analysis of 27 oncological patients examined in PET/CT and PET/MR. A novel motion-robust 3D ultrashort-echo-time (UTE) MR sequence was evaluated in comparison with CT and conventional breath-hold MR. CT scans were performed under breath-hold in end-expiratory and end-inspiratory position (CT ex, CT in). MR data was acquired with non-contrast-enhanced breath-hold Cartesian VIBE followed by a free-breathing 3D UTE Spiral VIBE. Impact of respiratory motion on pulmonary evaluation was investigated by two readers in Cartesian VIBE, followed by UTE Spiral VIBE and CT ex and the reference standard of CT in. Diagnostic accuracy was calculated, and visual image quality assessed., Results: Higher detection rate and sensitivity of pulmonary nodules in free-breathing UTE Spiral VIBE in comparison with breath-hold Cartesian VIBE were found for lesions > 10 mm (UTE Spiral VIBE/VIBE/CT ex): 93%/54%/100%; Lesions 5-10 mm: 67%/25%/ 92%; Lesions < 5 mm: 11%/11%/78%. Lobe-based analysis revealed sensitivities and specificities of 64%/96%/41% and 96%/93%/100% for UTE Spiral VIBE/VIBE/CT ex., Conclusion: Free-breathing UTE Spiral VIBE indicates higher sensitivity for detection of pulmonary nodules than breath-hold Cartesian VIBE and is a promising but time-consuming approach. However, sensitivity and specificity of inspiratory CT remain superior in comparison and should be preferred for detection of pulmonary lesions., (© 2021. The Author(s).)