64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum)
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- STATUS
- Recruiting
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- End date
- Jan 17, 2026
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- participants needed
- 70
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- sponsor
- Institut Cancerologie de l'Ouest
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
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.
Details
| Condition | Rectal Cancer |
|---|---|
| Treatment | 64Cu-ATSM |
| Clinical Study Identifier | NCT03951337 |
| Sponsor | Institut Cancerologie de l'Ouest |
| Last Modified on | 7 October 2022 |
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