Evaluation of the 64Cu-ATSM PET-CT as a predictor of the response to neo-adjuvant treatment in locally advanced rectal cancers

Evaluation of the 64Cu-ATSM PET-CT as a predictor of the response to neo-adjuvant treatment in locally advanced rectal cancers - TEP-64Cu-ATSM-Rectum

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002079-17-FR

Enrollment

Registered

2018-07-13

Start date

2018-10-16

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

men and / or women older than 18, newly diagnosed for locally advanced rectal cancer MedDRA version: 20.0 Level: PT Classification code 10038019 Term: Rectal adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: 64Cu-ATSM Product Code: 64Cu-ATSM Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the intensity of the tumor uptake of 64Cu-ATSM as a predictor of the histological response (estimated by a Rödel score of 3 or 4) to neo-adjuvant therapy by radiochemotherapy according to the CAP 50 regimen in 25 fractions of 2 Gy, in patients with locally advanced rectal cancer;Secondary Objective: ;Primary end point(s):	—

Countries

France

Contacts

Public ContactDRCI

INSTITUT DE CANCEROLOGIE DE L'OUEST

laetitia.himpe@ico.unicancer.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026