Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma (TEPIREC)

June 16, 2026 updated by: Centre Paul Strauss
With 50 patients included, this trial would be the largest pilot study evaluating the value of MRI PET in locally advanced rectal cancer. On the other hand, it would be the only pilot study performing several MRI PET during neoadjuvant treatment. Presumably, the response assessed at the 2nd MRI PET (before cycle 4 or induction chemotherapy) would be predictive of the overall response at the end of neoadjuvant treatment. Then, it would be possible to predict precociously the tumor response.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The management of localized rectal cancer is done in two phases. The first phase, medical, combines a possible first chemotherapy, followed by a concomitant chemoradiotherapy. The second phase, 6 to 8 weeks later, consists of surgery of the rectum.

Magnetic resonance imaging (MRI) of the pelvis allows staging of the tumor and its possible lymph node extensions. MRI can also be used to assess tumor response after the first phase of treatment and before surgery. But MRI of the pelvis is partially imperfect.

PET-MRI is an examination that combines MRI with an injection of [18 F]fluorodeoxyglucose (18F-FDG). It is known to be more sensitive in assessing tumor stage and lymph node extensions compared to MRI and more sensitive in assessing tumor response before surgery.

The aim of this study is to determine predictive parameters for response to the first phase of treatment by accurately identifying the characteristics of tumors that have responded or not to treatment with chemotherapy and chemoradiotherapy.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67033
        • Recruiting
        • Institut de cancérologie Strasbourg Europe
        • Contact:
        • Principal Investigator:
          • Laure KUNTZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient with histologically proven rectal cancer with an indication for induction chemotherapy followed by neoadjuvant chemoradiotherapy

Description

Inclusion Criteria:

  • World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) 0 to 2
  • Histologically proven rectal cancer
  • clinical tumor classification (cT) : cT3 - cT4 or all T / N+ / M0
  • Tumor resectable or considered resectable after chemoradiotherapy
  • Decision chemotherapy followed by neoadjuvant chemoradiotherapy decided at the organ Multidisciplinary Meeting
  • Absence of distant metastases
  • Adequate contraception for women of childbearing potential
  • Free, signed and informed consent
  • For women of childbearing potential : negative pregnancy test

Exclusion Criteria:

  • Subject with Uncontrolled diabetes
  • Contraindication to surgery
  • Contraindication to MRI
  • Contraindication to PET scan
  • Contraindication to chemotherapy
  • History of pelvic radiotherapy
  • History of major co-morbidity that may prevent treatment and no active infection (HIV or chronic hepatitis B or C)
  • Colloid (mucinous) adenocarcinoma
  • Presence of distant metastases
  • Contraindication to 5-FluoroUracil (FU), oxaliplatin or irinotecan
  • History of known Gilbert's disease
  • Patient with known UGT1A1 genotype
  • Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
  • Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
  • Medical history of angina or myocardial infarction.
  • Active progressive infection or any other serious medical condition that could compromise the administration of the treatment
  • Other concurrent cancer, or medical history of cancer other than treated in situ cervical carcinoma or basal cell carcinoma or squamous cell carcinoma
  • Patient enrolled in another clinical trial testing an investigational agent
  • Pregnant or breastfeeding woman
  • Persons deprived of their freedom or under guardianship or incapable of giving consent
  • Any psychological, familial, sociological or geographic condition that may interfere with the study protocol or follow-up schedule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult population with rectal cancer
Other: PET-MRI

Each patient will have a pre-treatment PET-MRI (PET-MRI 1) within 21 days before the start of treatment.

Induction chemotherapy may be performed at another center than the investigating center.

After 3 cycles of induction chemotherapy and before the 4th cycle, a second PET MRI (PET MRI 2) will be performed. In patients who have received less than 3 cycles of induction chemotherapy, this mid-therapy PET-MRI will not be performed.

A 3rd PET-MRI will be performed prior to radiation therapy (PET-MRI 3). A final MRI PET (MRI PET 4) will take place before surgery.

A total of 4 PET MRI scans will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of metabolic criteria.
Time Frame: At the surgery

The purpose of this study is to determine predictive parameters for response to the first phase of treatment by accurately identifying the characteristics of tumors that have responded or not to chemotherapy and chemoradiotherapy.

Metabolic criteria will be measured with the SUVmax values that will be determined on the 4 PET-MRI scans.
At the surgery
Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of MRI criteria.
Time Frame: At the surgery
MRI criteria will be measured with the Apparent Diffusion Coefficient (ADC) values that will be determined on the 4 PET-MRI scans.
At the surgery
Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of anatomopathological criteria.
Time Frame: At the surgery
Anatomopathological criteria will be measured with the histopathological response to treatment which will be defined according to the tumor regression grade (TRG)
At the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of tumor volumes
Time Frame: At the PET MRI pretherapy (= PET MRI 1)
Record of tumor volumes on MRI PET 1
At the PET MRI pretherapy (= PET MRI 1)
Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of SUVmax values
Time Frame: At the PET MRI pretherapy (= PET MRI 1)
Record of SUVmax on MRI PET 1
At the PET MRI pretherapy (= PET MRI 1)
Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of ADC values
Time Frame: At the PET MRI pretherapy (= PET MRI 1)
Record of ADC on MRI PET 1
At the PET MRI pretherapy (= PET MRI 1)
Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta tumor volume
Time Frame: At the 2nd PET (PET2), up to 28 months
Record of delta tumor volume, compared to baseline (PET MRI 1)
At the 2nd PET (PET2), up to 28 months
Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta SUVmax values
Time Frame: At the 2nd PET (PET2), up to 28 months
Record of delta SUVmax, compared to baseline (PET MRI 1)
At the 2nd PET (PET2), up to 28 months
Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta ADC values
Time Frame: At the 2nd PET (PET2), up to 28 months
Record of delta ADC, compared to baseline (PET MRI 1)
At the 2nd PET (PET2), up to 28 months
Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta tumor volume
Time Frame: At the 3rd PET (PET3), up to 28 months
Record of delta tumor volume, compared to baseline (PET MRI 1)
At the 3rd PET (PET3), up to 28 months
Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta SUVmax values
Time Frame: At the 3rd PET (PET3), up to 28 months
Record of delta SUVmax, compared to baseline (PET MRI 1)
At the 3rd PET (PET3), up to 28 months
Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta ADC values
Time Frame: At the 3rd PET (PET3), up to 28 months
Record of delta ADC, compared to baseline (PET MRI 1)
At the 3rd PET (PET3), up to 28 months
Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta tumor volume
Time Frame: At the 4th PET (PET4), up to 28 months
Record of delta tumor volume, compared to PET3
At the 4th PET (PET4), up to 28 months
Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta SUVmax values
Time Frame: At the 4th PET (PET4), up to 28 months
Record of delta SUVmax, compared to PET3
At the 4th PET (PET4), up to 28 months
Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta ADC values
Time Frame: At the 4th PET (PET4), up to 28 months
Record of delta ADC, compared to PET3
At the 4th PET (PET4), up to 28 months
Propose standardized criteria to differentiate responders from non-responders
Time Frame: Data record throughout the study, up to 28 months
Record of clinical and iconographic data predictive of good response to treatment
Data record throughout the study, up to 28 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Paul Strauss

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2023

Primary Completion (Estimated)

September 18, 2026

Study Completion (Estimated)

July 25, 2030

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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