Organ-sparing With TraceIT® for Rectal Cancer Radiotherapy

This is a feasibility prospective pilot study. Ten patients (5 males and 5 females) with a histologically proven locally advanced rectal cancer with the indication of neoadjuvant radiotherapy or radio-chemotherapy will be recruited for this study. Prior to enrollment, potential candidates will undergo a thorough physical and clinical examination and documentation on medical and surgical history. If eligible, a baseline planning computed tomography (CT) simulation will be performed at the Radiation Oncology Department before the TraceIT® implant. Participants will undergo a transperineal injection of TraceIT® spacer gel between rectum and vagina or prostate performed by a trained radiologist under transrectal ultrasound guidance. A CT simulation will be repeated within 3 to 5 days post injection using the same imaging modality and treatment position used the pre- TraceIT® injection. Radiation treatment plans will be generated using scans realized pre- and post- TraceIT® injection and compared using dose volume histograms (DVH) analyses. Tolerance, side effects, and adverse events related to the procedure will be recorded prospectively from the injection until week-4 after EBRT (External Beam Radiation Therapy) completion. Radiological status of the spacer will be evaluated on the preoperative magnetic resonance Imaging (MRI). Histopathological results and any serious and/or unanticipated adverse events following surgery procedure will be recorded retrospectively.