Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: 1. Patient over 18 years old. 2. Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated. 3. Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1 4. Signed consent to participation. 5. For women of childbearing age, effective contraception must also be agreed for the duration of treatment. 6. Affiliation to a social security regimen, or beneficiary of such a regimen. Exclusion Criteria: 1. Predominant mucinous component on initial MRI, biopsy and / or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs. 2. Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia). 3. Exclusive radiation therapy. 4. Other associated neo-adjuvant treatment. 5. Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure. 6. Contraindications to capecitabine: Severe hepatic impairment, severe renal impairment (creatinine clearance \<30 ml / min), 7. Known deficiency of Dihydropyrimidine dehydrogenase (DPD), known hypersensitivity to 5-FU / capecitabine and / or its excipients. 8. Participation in a protocol with concurrent treatment. 9. Pregnant or likely to be pregnant (without effective contraception) or breastfeeding 10. Person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his / her consent. 11. Impossibility of attending the medical examination of the test for geographical, social or psychological reasons.
Study sites (1)
CA
- University of California Los Angeles (UCLA) · Los Angeles, CA 90095-1406Percy LEE, MD · Study contactPercy LEE · Principal investigatorMore trials in Los Angeles