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

Sponsor

Institut de cancérologie Strasbourg Europe (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05772481

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Other: PET-MRI

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

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of metabolic criteria. [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. [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. [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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Adequate hematologic function
Adequate liver function
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)
Hypofractionated radiotherapy according to the Swedish protocol (25 Gy in 5 fractions)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de cancérologie Strasbourg Europe	Strasbourg		France	67033

Sponsors and Collaborators

Institut de cancérologie Strasbourg Europe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut de cancérologie Strasbourg Europe

ClinicalTrials.gov Identifier:

NCT05772481

Other Study ID Numbers:

2022-007

First Posted:

Mar 16, 2023

Last Update Posted:

Mar 16, 2023

Last Verified:

Mar 1, 2023

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of Mar 16, 2023