Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
NCT ID: NCT05772481
Last Updated: 2023-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2023-05-19
2025-09-19
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Adult population with rectal cancer
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Institut de cancérologie Strasbourg Europe
OTHER
Responsible Party
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Locations
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Institut de cancérologie Strasbourg Europe
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-007
Identifier Type: -
Identifier Source: org_study_id
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