Rectal Cancer Response Hybrid Imaging Assessement (RECARHIA)
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|ClinicalTrials.gov Identifier: NCT04036643|
Recruitment Status : Not yet recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
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:
- 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
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Radiation: PET-MRI||Not Applicable|
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 examination will be interpreted (sequences identical to that performed in conventional MRI), without the PET part of the examination. An evaluation of the answer will be done. The results of the MRI will be transmitted to the surgeon in accordance with the conventional attitude of treatment of rectal cancer treated with RCT.
In a second step the complete examination associating the merged MRI and PET sequences will be reinterpreted. A new evaluation of the response will be done. The results of the MRI and PET MRI will be read without the gold standard, which will be available after the intervention. The results of this second analysis will not be transmitted to the Multidisciplinary Concertation Meeting and will not influence the management. The patients will then be operated. The histological stage ypTN will be established on the operative specimen.
Thus all patients will have the 2 tests under study (MRI and [18F] -FDG-PET / MRI, as well as the gold standard (pathological analysis) .These results will meet the main objective evaluation of the diagnostic performances by comparing them with the results of the gold standard (anatomopathological analysis of the operative specimen)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patient with rectal cancer treated by neoadjuvant chemo radiation therapy with clinical complete response|
|Masking:||None (Open Label)|
|Official Title:||Contribution of [18F] -FDG-PET / MRI in the Detection of the Absence of Complete Response After Neo-adjuvant Radiotherapy for Cancers of the Middle and Low Rectum for a Treatment Procedure With Rectal Savings|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: patient with rectal cancer
Patient with rectal cancer treated by neoadjuvant chemo-radiation therapy with clinical complete response
Hybrid PET / MRI machine for simultaneous acquisition of functional and molecular information of different natures coupled with the high anatomical resolution of MRI.
- 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 [ Time Frame: Up to 3 months ]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
- Calculation of the Net Reclassification Index (NRI) by comparing the sensitivity of [18F] -FDG-PET / MRI and the sensitivity of MRI alone for TRG1 [ Time Frame: Up to 3 months ]Number of patient correctly reclassified with [18F] -FDG-PET as having a complete response (no residual tumor visible) divided by the number of patient correctly classified with [18F] -FDG-PET as having a complete response (no residual tumor visible)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036643
|Contact: LUCIDARME Olivier, PU-PHemail@example.com|
|Contact: WAGNER Mathilde, PHfirstname.lastname@example.org|
|Groupe Hospitalier Pitié-Salpêtrière||Not yet recruiting|
|Paris, France, 75013|
|Contact: LUCIDARME Olivier, PU-PH 33142176322 email@example.com|
|Principal Investigator:||LUCIDARME Olivier, PU-PH||AP-HP Groupe Hospitalier Pitié Salpêtrière - Radiology Department|