Status:
UNKNOWN
Rectal Cancer Response Hybrid Imaging Assessement
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rectal cancer represents 14,000 new cases a year in France. At diagnosis, 70% of patients have a locally advanced tumors T3-T4 and / or N + evaluated mainly by rectal MRI. These patients will benefit ...
Detailed Description
The MRI examination to evaluate the response to routine Radio-Chemotherapy Neoadjuvant (RCT) will be replaced by an MRI-PET scan in all patients included. Firstly, only the MRI portion of the examinat...
Eligibility Criteria
Inclusion
- Adult patients age ≥18 years
- Patients with a rectal cancer and who had neo-adjuvant treatment by radio-chemotherapy
- Patients for whom the clinical and endoscopic examination realised 6 at 9 weeks after the end o the RCT is in favour of a complete response (normal digital rectal exam, endoscopic complete disappearance of the lesion or the presence of scar and whitish plane of less than 2 cm)
- Patients who have signed a consent formulary after a loyal and fair information
- Patients affiliated to a social security scheme (beneficiary or legal) outside AME
Exclusion
- Patients with a contraindication to MRI: pacemaker, defibrillator, intraocular metallic foreign body, ferromagnetic implant, claustrophobia
- Patient with a contraindication to PET: non controlled diabet glycemia \> 200 mh/dL, pregnancy
- Hypersensibility to 18-FDG or others contrast products
- Patients who would require abdominoperineal amputation
- Patients with many comorbidities contraindicating MTCT because these patients do not match the target population (in addition they currently represent the rare indications of closure lumpectomy)
- Patients under guardianship or reinforced curators or deprived of liberty.
- Pregnant or childbearing women without effective contraception (a plasma βHCG test will be performed in this case the day before PET / MRI)
- Participation in another interventional research without the agreement of the physician following the patient for research
Key Trial Info
Start Date :
November 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04036643
Start Date
November 27 2019
End Date
February 1 2023
Last Update
February 5 2020
Active Locations (1)
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1
Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013