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Recruiting NCT05772481

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

— Observational Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PET-MRI.
Who it may be relevant to
Registry conditions: Rectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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-

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. [Time frame: 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]
  • 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]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Institut de cancérologie Strasbourg Europe — Strasbourg

Identifiers

NCT: NCT05772481 · 2022-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗