64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum)

Status Active, not recruiting

Clinical Trial Summary

This phase II trial is assessing how 64Cu-ATSM (64Cu-copper(II) diacetylbis(N4-methylthiosemicarbazone)) PET/CT scan could predict neo adjuvant treatment response in rectum cancer locally advanced

Clinical Trial Description

The purpose of this study is to evaluate early and late tumor uptake of 64Cu-ATSM in predicting histological response to neo-adjuvant chemo-radiotherapy treatment in patients with locally advanced rectal cancer. Patients receive pre-therapeutic CT scan, Pelvic MRI and 18FDG (fluorodeoxyglucose) PET/CT (positron emission tomography) scan within 45 days before enrollment. 64Cu-ATSM PET/CT scan is done before chemoradiotherapy treatment start. About 3 MBq/Kg of 64Cu-ATSM are injected intravenously, two acquisition sequences are performed 1 hour and 23 to 25 hours after injection in order to evaluate early and late tumor uptake of 64Cu-ATSM. Patients are treated for 5 weeks by Capecitabine chemotherapy (1600 mg/m2/day) combined to 50 Gy radiotherapy. Pelvic MRI is performed 4 weeks after chemotherapy in order to evaluate the treatment efficacy. Surgery is scheduled 6 to 8 weeks after chemoradiotherapy. Tissue samples from previously collected rectal biopsy (obtained for diagnosis) and from surgery are used for assessing oxidative stress markers by Immuno-histochemical analysis. Chest, abdomen and pelvis CT scan is performed every 6 months after surgery in order to assess progression free survival. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03951337
Study type	Interventional
Source	Institut Cancerologie de l'Ouest
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	April 26, 2019
Completion date	January 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06380101` - Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)	N/A
Active, not recruiting	`NCT05551052` - CRC Detection Reliable Assessment With Blood
Recruiting	`NCT04323722` - Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer	N/A
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT04088955` - A Digimed Oncology PharmacoTherapy Registry
Active, not recruiting	`NCT01347697` - Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer	N/A
Recruiting	`NCT04495088` - Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer	Phase 3
Withdrawn	`NCT03007771` - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia	Phase 1
Terminated	`NCT01347645` - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer	Phase 1/Phase 2
Not yet recruiting	`NCT03520088` - PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS	N/A
Recruiting	`NCT05556473` - F-Tryptophan PET/CT in Human Cancers	Phase 1
Recruiting	`NCT04749381` - The Role of TCM on ERAS of Rectal Cancer Patients	Phase 2
Enrolling by invitation	`NCT05028192` - Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
Recruiting	`NCT03283540` - Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
Completed	`NCT04534309` - Behavioral Weight Loss Program for Cancer Survivors in Maryland	N/A
Recruiting	`NCT05914766` - An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer	N/A
Recruiting	`NCT04852653` - A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
Recruiting	`NCT03190941` - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients	Phase 1/Phase 2
Completed	`NCT02810652` - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection	N/A
Terminated	`NCT02933944` - Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer	Phase 1