Clinical trial · Interventional
64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum)
Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer
NCT03951337CI-TRIAL-00074916unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 64Cu-ATSM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 64Cu ATSM
- description
- pretherapeutic 64Cu-ATSM PET/CT scan
- interventionNames
- Drug: 64Cu-ATSM
Primary outcomes (1)
- measure
- Relationship between early tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment
- timeFrame
- 4 months
- description
- Early tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement, histological response Will be assessed by Rodel grading (Tumor Regression Grading)
Secondary outcomes (6)
- measure
- Relationship between late tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed rectum adenocarcinoma * Locally advanced, non metastatic disease, with or without locoregional lymph node involvement (greater than or equal to T3 +/- N), first-line therapy * 18 Years and older * Performance Status equal to 0 or 1 * Fertile patients must use effective contraception * Hemoglobin greater than 9g/dl, neutrophils greater than 1 500/mm3, platelets greater than 100 000/mm3 * Creatinine clearance greater than or equal to 50ml/min * Plan to receive treatment with concurrent chemotherapy and radiation therapy followed by surgery * Totality of the tumor included in the radiotherapy field * Written informed consent * Patient must be affiliated to a Social Health Insurance Exclusion Criteria: * metastatic disease * Patient contraindicated for capecitabine or 5FU (5-Fluoro-Uracile) derivatives (history of severe and unexpected reactions to fluoropyrimidine-containing therapy, known hypersensitivity to 5FU, to any of the excipients, or known total DPD (dihydropyrimidine déshydrogénase) deficiency) * Known Contraindication to perform MRI * Previous treatment with pelvic radiotherapy * Chronic inflammatory bowel disease, malabsorption, lack of colonic integrity * Diarrhea grade greater than 2 * Contraindication to surgery * Bilateral total hip prosthesis * Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix) * Pregnant or nursing patient * Individual deprived of liberty or placed under the authority of a tutor * Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons * Agitation; impossibility of lying motionless for at least 1 hour, or known claustrophobia
References
Publications (0)
Data not yet available
No reference posted for this study.