Search

Hintergrund: Magnetische Seeds k��nnen anstelle der herk��mmlichen F��hrungsdr��hte zur Markierung okkulter Brustl��sionen verwendet werden, sollen die Zufriedenheit der Patient*innen und Behandler*innen verbessern und die Operationsplanung vereinfachen. Anders als die wenig reliable subjektive Beurteilung der Gewebeperfusion k��nnte die intraoperative Indocyaningr��n(ICG)-Fluoreszenzangiographie die objektive Detektion isch��mischer Areale in der rekonstruktiven Brustchirurgie erm��glichen und mithin die postoperative Komplikationsrate verringern. Alternativ zum radioaktiven Technetium stehen f��r die Sentinelmarkierung beim Mammakarzinom mittlerweile eisenhaltige Tracer (SPIO) zur Verf��gung, die die Prozedur von nuklearmedizinischen Fachabteilungen l��sen und ebenfalls logistische Vereinfachungen versprechen. Methoden: Im Brustzentrum der Charit�� ist jeweils eine Studie zur Tumormarkierung mittels magnetischer Seeds, zur intraoperativen ICG-Angiographie und zur SPIO-basierten Sentinelbiopsie durchgef��hrt worden. Dabei wurden die Daten von Patientinnen in herk��mmlicher und neuer Versorgung verglichen. Prim��rer Endpunkt der Seed-Studie war die Tumorresektionszeit, den sekund��ren Endpunkt stellte der Schmerz der Patientinnen nach Draht- bzw. Seedmarkierung dar. In der ICG-Studie wurden die Patientinnen hinsichtlich der postoperativen Wundheilungsst��rungen und des Patient-Reported Outcomes (PRO) nach Operation mit ICG-Angiographie oder ohne zus��tzliche Perfusionsmessung verglichen. Die SPIO-Studie untersuchte prim��r die pr��operative Vorbereitungszeit und sekund��r die Verg��tung der Sentinelbiopsie mittels Technetiums bzw. SPIO. Ergebnisse: Jeweils 14 Patientinnen der Seed-Studie erhielten pr��operativ eine Drahtmarkierung bzw. magnetische Seedmarkierung. Die Tumorresektionszeit unterschied sich nicht signifikant, jedoch gaben die Seed-Patientinnen signifikant geringere postinterventionelle Schmerzen an (1 [0,5���2,5] vs. 4 [3���4]; p, Background: Magnetic seeds can be used instead of conventional guide-wires to mark occult breast lesions. They are expected to improve patient and practitioner satisfaction, and to facilitate surgery scheduling. Unlike the less reliable subjective clinical assessment of tissue perfusion, intraoperative indocyanine green (ICG) fluorescence imaging could allow objective detection of ischemic areas in reconstructive breast surgery and thereby reduce the postoperative complication rate. As an alternative to radioactive technetium, iron-containing tracers (SPIO) are available for localizing the sentinel lymph node during breast cancer surgery. SPIO detaches the procedure from nuclear medicine departments and promises logistical simplifications. Methods: At Charit�� Breast Center, one study each has been performed on tumor localization using magnetic seeds, intraoperative ICG-imaging and SPIO-based sentinel node biopsy. Data from patients undergoing conventional surgery and new approaches of care were compared. The primary endpoint of the seed study was tumor resection time, the secondary endpoint represented patient pain levels after guide-wire or seed marking. The ICG study compared patients with regard to postoperative wound healing disorders and patient-reported outcome after surgery with or without ICG-angiography. The SPIO study primarily assessed preoperative preparation time and secondarily reimbursement for sentinel node biopsy using technetium or SPIO. Results: In the seed study, 14 patients each received preoperative wire marking or magnetic seed marking. Tumor resection time did not differ significantly, but seed patients reported significantly lower post-interventional pain (1 [0.5-2.5] vs. 4 [3-4]; p

Background Despite the progress of research and treatment for breast cancer, still up to 30% of the patients afflicted will develop distant disease. Elongation of survival and maintaining the quality of life (QoL) become pivotal issues guiding the treatment decisions. One possible approach to optimise survival and QoL is the use of patient-reported outcomes (PROs) to timely identify acute disease-related burden. We present the protocol of a trial that investigates the effect of real-time PRO data captured with electronic mobile devices on QoL in female breast cancer patients with metastatic disease. Methods This study is a randomised, controlled trial with 1:1 randomisation between two arms. A total of 1000 patients will be recruited in 40 selected breast cancer centres. Patients in the intervention arm receive a weekly request via an app to complete the PRO survey. Symptoms will be assessed by study-specific optimised short forms based on the EORTC QLQ-C30 domains using items from the EORTC CAT item banks. In case of deteriorating PRO scores, an alarm is sent to the treating study centre as well as to the PRO B study office. Following the alarm, the treating breast cancer centre is required to contact the patient to inquire about the reported symptoms and to intervene, if necessary. The intervention is not specified and depends on the clinical need determined by the treating physician. Patients in the control arm are prompted by the app every 3 months to participate in the PRO survey, but their response will not trigger an alarm. The primary outcome is the fatigue level 6 months after enrolment. Secondary endpoints include among others hospitalisations, use of rescue services and overall QoL. Discussion Within the PRO B intervention group, we expect lower fatigue levels 6 months after intervention start, higher levels of QoL, less unplanned hospitalisations and less emergency room visits compared to controls. In case of positive results, our approach would allow a fast and easy transfer into clinical practice due to the use of the already nationwide existing IT infrastructure of the German Cancer Society and the independent certification institute OnkoZert. Trial registration DRKS (German Clinical Trials Register) DRKS00024015. Registered on 15 February 2021 Supplementary Information The online version contains supplementary material available at 10.1186/s13063-021-05642-6.

Additional file 2. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*.

Additional file 1. Consent form for patients treated at Charité - Universitätsmedizin Berlin (German).