Rectal Cancer Response Hybrid Imaging Assessement

NCT04036643 | Unknown

• 1 other identifier: P170939J
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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 from a neo-adjuvant treatment by radio-chemotherapy. The complete histologic response rate (ypT0N0) after this neo-adjuvant treatment ranged from 15 to 27% and improved recurrence-free survival, remotely relapse-free survival, overall survival, and decreased local recurrence rate. In the case of full response diagnosis after neoadjuvant chemoradiotherapy 3 theoretical solutions exist:

1. 1.Total excision of the rectum and mesorectum (TME) This is the classic attitude with a low risk of local recurrence (5%) but functional complications occur in 25 to 60% of cases
2. 2.A simple monitoring ("Watch and Wait") by MRI, biopsy, rectoscopy ... This strategy was initially proposed to elderly patients considered inoperable but it has also been proposed in younger patients, operable, with a view to decreasing morbidity and sequelae. This attitude poses a likely overall risk of local recidivism. However, this higher risk of recurrence may be the result of imperfect identification of ypT0N0 patients.
3. 3.Local excision of the post-radiation scar also called closure lumpectomy with pathological analysis and possible secondary TME if no complete response. This last attitude has the advantage of allowing an anatomopathological verification of the treated lesion and to complete the treatment if necessary. In the case of ypT0 the local recurrence rate is low and in this case it is possible to consider rectal savings.

Conditions

Rectal Cancer

Keywords

Rectal neoplasm; Imaging TEP/MRI; response assessement

Outcome Measures

Primary Outcomes (1)

• Tumor response assessed by modified the Ryan tumor regression grading system obtained by quantification of the residual cancer cells compared to fibrosis on the surgical specimen

  After surgery the tumor response will be graded TRG 1 (no residual cancer cells), 2 (residual cancer outgrown by fibrosis) or 3 (fibrosis outgrown by cancer cells). MRI and \[18F\] -FDG-PET / MRI results (residual tumor or no residual tumor) will be compared to TRG results and Sensitivity and specificity of MRI and \[18F\] -FDG-PET / MRI for TRG1 will be calculated

  Up to 3 months

Secondary Outcomes (1)

• Calculation of the Net Reclassification Index (NRI) by comparing the sensitivity of [18F] -FDG-PET / MRI and the sensitivity of MRI alone for TRG1

  Up to 3 months

Study Arms (1)

patient with rectal cancer

EXPERIMENTAL

Patient with rectal cancer treated by neoadjuvant chemo-radiation therapy with clinical complete response

Radiation: PET-MRI

Interventions

PET-MRI RADIATION

Hybrid PET / MRI machine for simultaneous acquisition of functional and molecular information of different natures coupled with the high anatomical resolution of MRI.

patient with rectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• LUCIDARME Olivier, PU-PH

  AP-HP Groupe Hospitalier Pitié Salpêtrière - Radiology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LUCIDARME Olivier, PU-PH

CONTACT

33142176322; olivier.lucidarme@aphp.fr

WAGNER Mathilde, PH

CONTACT

mathilde.wagner@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patient with rectal cancer treated by neoadjuvant chemo radiation therapy with clinical complete response

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 30, 2019
• Study Start: November 27, 2019
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

FR (1)