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

Rectal Cancer Clinical Trial

Official title:

Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03951337
• Other study ID #: ICO-N-2017-14
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 26, 2019
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: January 2026
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• 64Cu-ATSM
64 Cu-ATSM PET/CT scan

Locations

Country	Name	City	State
France	Institut de Cancerologie de l'Ouest (ICO)	Angers
France	CHU de BREST	Brest
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Institut de cancerologie de l'Ouest	Saint Herblain

Sponsors (2)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest	Fondation ARC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between early tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment	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)	4 months
Secondary	Relationship between late tumor uptake of 64Cu-ATSM PET/CT images and prediction of histological response to neo-adjuvant chemo-radiotherapy treatment	Late 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)	4 months
Secondary	Correlation between 64Cu-ATSM uptake and oxidative stress markers	Aggressive zones corresponding to high redox potential areas will be assessed by Immuno-histochemical analysis on the surgical sample and on the pre-therapeutic biopsy	4 months
Secondary	Progression free survival	Progression Free survival is the delay between surgery and the date of documented disease progression	2 years
Secondary	18FDG-PET/CT and 64Cu-PET/CT uptakes	Correlation between 18FDG-PET/CT and 64Cu-PET/CT uptakes	45 days
Secondary	Comparison between early and late 64Cu-ATSM uptakes in 64Cu-ATSM PET/CT images	Early and Late tumor uptake of 64Cu-ATSM will be assessed by SUV (Standardized Uptake Value) measurement	45 days
Secondary	64Cu-ATSM toxicity	64Cu-ATSM toxicity will be assessed by vital signs monitoring within 2 hours after 64Cu-ATSM injection	45 days