Hyperpolarized 13C-MMRI and Metabolomics in Rectal Cancer
Official title: Integrated Precision Imaging for Rectal Cancer Patients Undergoing Total Neoadjuvant Therapy: Hyperpolarized 13C-MRI, Metabolomics, and Radiomics
Run by Chang Gung Memorial Hospital · NCT07730541 · Data updated 2026-11-12
This study tests whether a special MRI method and metabolic analysis can better predict how rectal cancer responds to chemoradiotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taoyuan) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | July 30, 2028 |
| Study ends | July 30, 2028 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT07730541 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with biopsy-confirmed rectal adenocarcinoma planned for neoadjuvant chemoradiotherapy who can undergo MRI.
✕Probably not a fit
Patients unable to undergo MRI or with conditions preventing safe participation or adherence to follow-up may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll 30 patients with biopsy-proven rectal adenocarcinoma undergoing neoadjuvant chemoradiotherapy. Participants will receive standard MRI, colonoscopy, and advanced metabolic imaging using hyperpolarized 13C-MRI before and after treatment, along with metabolomics and radiomics analysis. The goal is to see if metabolic changes and radiomic features can predict pathological complete response earlier and more accurately than conventional imaging. The study compares outcomes between patients who achieve complete tumor response and those who do not, aiming to inform treatment decisions and avoid unnecessary surgery. Dynamic nuclear polarization enhances 13C signals to probe metabolic fluxes related to glycolysis and the TCA cycle in vivo.
Why it matters
Potential benefit: If successful, this approach could enable earlier and more accurate prediction of complete tumor response, potentially guiding less invasive management.
How similar studies have gone: Prior work suggests metabolic imaging and radiomics can add value in cancer treatment assessment, but this exact combination in rectal cancer after nCRT is relatively novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with biopsy proved rectal adenocarcinoma. 2. Patents will undergo neoadjuvant chemoradiation therapy (nCRT). 3. Patients more than 20-year-old. Exclusion Criteria: 2\. Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI). 3. Intercurrent illness that will affect the compliance of the patient during the MRI study (e.g., active infection, symptomatic congestive heart failure, uncontrollable angina, arrhythmia, psychiatric disorders, dyspnea, or diarrhea). 4. Severe hepatic dysfunction (alkaline phosphatase/aspartate aminotransferase/alanine aminotransferase \>20 × upper limit of normal \[ULN\] or bilirubin \> 10 × ULN). 5. Severe renal impairment (eGFR \<30 ml/min/1.73m2).
Where it's running
-
Chang Gung Memorial hospital
Taoyuan, Taiwan Recruiting
Study contacts
- Principal investigator: Ying-Chieh Lai, MD — Chang Gung Memorial Hospital, Link
- Study coordinator: Ying-Chieh Lai, MD
- Email: cappolya@gmail.com
- Phone: +88633281200
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.