Rectal CancerRECARHIANCT04036643
Rectal Cancer Response Hybrid Imaging Assessement
A study testing PET-MRI in people with Rectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- PET-MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2019to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
WAGNER Mathilde, PH contact
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
LUCIDARME Olivier, PU-PH, 33142176322, olivier.lucidarme@aphp.fr
About this study
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
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.
Read the 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 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)
- Conditions
- Rectal Cancer
- Being tested
- PET-MRI
- Keywords
- Rectal neoplasm, Imaging TEP/MRI, response assessement
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRIRadiation
Hybrid PET / MRI machine for simultaneous acquisition of functional and molecular information of different natures coupled with the high anatomical resolution of MRI.
| Study group | Role | What they receive |
|---|---|---|
| patient with rectal cancer | Experimental | Patient with rectal cancer treated by neoadjuvant chemo-radiation therapy with clinical complete response Receives: Radiation: PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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)
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start27 Nov 2019
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patient with rectal cancer treated by neoadjuvant chemo radiation therapy with clinical complete response
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LUCIDARME Olivier, PU-PH, Principal investigator, AP-HP Groupe Hospitalier Pitié Salpêtrière - Radiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036643
- Sponsor's protocol ID
- P170939J
- Acronym
- RECARHIA
- Status last verified
- Jan 2020
- First submitted
- 1 Jul 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04036643
- Acronym / sponsor ID
- RECARHIA / P170939J
- Conditions
- Rectal Cancer
- Keywords
- Rectal neoplasm, Imaging TEP/MRI, response assessement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patient with rectal cancer treated by neoadjuvant chemo radiation therapy with clinical complete response
| Arm | Type | Receives |
|---|---|---|
| patient with rectal cancer | Experimental | Radiation: PET-MRIPatient with rectal cancer treated by neoadjuvant chemo-radiation therapy with clinical complete response |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-MRIHybrid PET / MRI machine for simultaneous acquisition of functional and molecular information of different natures coupled with the high anatomical resolution of MRI. | Radiation | patient with rectal cancer |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WAGNER Mathilde, PH contact
LUCIDARME Olivier, PU-PH principal investigator
AP-HP Groupe Hospitalier Pitié Salpêtrière - Radiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MRI in people with Rectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LUCIDARME Olivier, PU-PH (33142176322, olivier.lucidarme@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.