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Rectal Cancer Response Hybrid Imaging Assessement

NCT04036643 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-02-05

No results posted yet for this study

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. 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. 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. 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.

The choice of the last two attitudes is therefore based on the correct identification of patients in complete response. The performance of the diagnosis of no complete response after radiochemotherapy is therefore fundamental and is the subject of this project wich consist of comparing he diagnostic performance for the identification of a complete lack of response \[18F\] -FDG-PET / MRI ypT0N0 to that of the classic attitude (MRI) 6 to 9 weeks after the end of a neoadjuvant chemoradiotherapy treatment of low and mid-rectal cancers in patients in whom clinical and endoscopic examination favor a complete response.

Conditions

Interventions

RADIATION

PET-MRI

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • LUCIDARME Olivier, PU-PH · AP-HP Groupe Hospitalier Pitié Salpêtrière - Radiology Department

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-27
Primary Completion
2022-12-31
Completion
2023-02-28

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04036643 on ClinicalTrials.gov