Rectal CancerTEPIRECNCT05772481
Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
An observational study of Rectal Cancer, run by Centre Paul Strauss at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- PET-MRI
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2023to 25 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with histologically proven rectal cancer with an indication for induction chemotherapy followed by neoadjuvant chemoradiotherapy
Who may be able to join
- 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
Show all 9Show fewer
- Adequate contraception for women of childbearing potential
- Free, signed and informed consent
- For women of childbearing potential : negative pregnancy test
Who cannot join
- Subject with Uncontrolled diabetes
- Contraindication to surgery
- Contraindication to MRI
- Contraindication to PET scan
- Contraindication to chemotherapy
- History of pelvic radiotherapy
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
Laure KUNTZ, l.kuntz@icans.eu
Laure KUNTZ
About this study
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- PET-MRI
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult population with rectal cancer | Not described Receives: Other: PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of metabolic criteria.
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.
Measured: 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.
MRI criteria will be measured with the Apparent Diffusion Coefficient (ADC) values that will be determined on the 4 PET-MRI scans.
Measured: 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.
Anatomopathological criteria will be measured with the histopathological response to treatment which will be defined according to the tumor regression grade (TRG)
Measured: At the surgery
Secondary outcomes (13)
Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of tumor volumes
Record of tumor volumes on MRI PET 1
Measured: 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
Record of SUVmax on MRI PET 1
Measured: 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
Record of ADC on MRI PET 1
Measured: 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
Record of delta tumor volume, compared to baseline (PET MRI 1)
Measured: 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
Record of delta SUVmax, compared to baseline (PET MRI 1)
Measured: 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
Record of delta ADC, compared to baseline (PET MRI 1)
Measured: 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
Record of delta tumor volume, compared to baseline (PET MRI 1)
Measured: 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
Record of delta SUVmax, compared to baseline (PET MRI 1)
Measured: 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
Record of delta ADC, compared to baseline (PET MRI 1)
Measured: 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
Record of delta tumor volume, compared to PET3
Measured: 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
Record of delta SUVmax, compared to PET3
Measured: 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
Record of delta ADC, compared to PET3
Measured: At the 4th PET (PET4), up to 28 months
Propose standardized criteria to differentiate responders from non-responders
Record of clinical and iconographic data predictive of good response to treatment
Measured: Data record throughout the study, up to 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start19 May 2023
- Primary completion18 Sep 2026 (estimated)
- Study completion25 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772481
- Sponsor's protocol ID
- 2022-007
- Acronym
- TEPIREC
- Status last verified
- Jun 2026
- First submitted
- 8 Feb 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05772481
- Acronym / sponsor ID
- TEPIREC / 2022-007
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 18 Sep 2026 (estimated)
- Study completion
- 25 Jul 2030 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult population with rectal cancer | – | Other: PET-MRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with histologically proven rectal cancer with an indication for induction chemotherapy followed by neoadjuvant chemoradiotherapy
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- Subject with Uncontrolled diabetes
- Contraindication to surgery
- Contraindication to MRI
- Contraindication to PET scan
- Contraindication to chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-MRIEach 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. | Other | Adult population with rectal cancer |
Primary outcome
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.
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.
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)
13 secondary outcomes
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)
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)
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)
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
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
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
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
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
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
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
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
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
Propose standardized criteria to differentiate responders from non-responders
Time frame: Data record throughout the study, up to 28 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Centre Paul Strauss at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon VOEGELIN (+33 6 68 33 95 23, promotion-rc@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.