Clinical trial · Interventional
Advanced MR Imaging for Early Biologic Tumor Changes to Neoadjuvant Chemoradiation Treatment for Rectal Cancer
Pilot Study of Advanced MR Imaging for Early Biologic Tumor Changes to Neoadjuvant Chemoradiation Treatment for Rectal Cancer
NCT01830582CI-TRIAL-00028221completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to see whether three new types of MRI techniques used during magnetic resonance imaging (MRI) of the pelvis to look at rectal cancer can help doctors to tell if the tumor is getting better in response to the radiation and/or chemotherapy treatments.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Advanced MR Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1 A
- description
- The patients will undergo the standard pre chemoradiation MRI scan, followed by a repeat research scan 24 hours (+/- 6 hours) after their first radiation treatment. Then they will get another research MRI scan during the second week (+/- 5 days) of radiation. Finally they will get a standard post chemoradiation MRI scan prior to surgery.
- interventionNames
- Procedure: Advanced MR Imaging
- type
- EXPERIMENTAL
- label
- 1 B
- description
- The patient will undergo the standard pre chemoradiation MRI scan, followed by a repeat research scan 48 hours (+/- 6 hours) after their first radiation treatment. Then they will get another research MRI scan during the third week (+/- 5 days) of radiation. Finally they will get a standard post chemoradiation MRI scan prior to surgery.
- interventionNames
- Procedure: Advanced MR Imaging
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with primary locally advanced rectal adenocarcinoma (0-18cm from the anal verge) confirmed by MSKCC pathologist and eligible to undergo chemoradiation and surgical resection at MSKCC. * Written informed consent * Age equal to or greater than 21 years * Willing and able to undergo all study procedures * Patients must have a planned surgical resection of the rectum Exclusion Criteria: * Patients younger than 21 years * Pregnant and nursing women * Contraindications for MRI (such as claustrophobia, pacemaker, non MR-compatible artificial heart valves, cochlear implants, surgical clips in the brain, metal fragments in eye) * Estimated GFR (using Cockcroft formula Appendix 2) less than 30 ml/min/1.73m2 (FDA advises caution in using gadolinium-based contrast agents in patients with severe renal impairment). * History of allergic reaction to MR contrast media * Inability to give informed consent in person
References
Publications (0)
Data not yet available
No reference posted for this study.