NCT07730541 Hyperpolarized 13C-MRI and Radiomics in Rectal Cancer
| NCT ID | NCT07730541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Neoadjuvant Chemoradiotherapy |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2028-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-06-01 with a primary completion date of 2028-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is testing new imaging and analysis methods to improve how doctors predict treatment response in rectal cancer patients receiving chemoradiotherapy. Current MRI scans sometimes miss complete tumor response, which can lead to unnecessary surgery. To address this, researchers will use a special MRI technique called hyperpolarized carbon-13 MRI, along with blood and tissue analysis (metabolomics) and advanced image feature analysis (radiomics). These tools can track how cancer cells use energy and how metabolism changes during treatment. The study will follow 30 rectal cancer patients at Chang Gung Memorial Hospital over 3 years. Patients will undergo standard MRI, colonoscopy, and advanced metabolic imaging before and after treatment. Results will compare patients whose tumors completely respond to therapy with those who do not. The goal is to see if metabolic changes detected by hyperpolarized MRI and metabolomics can predict treatment outcomes earlier and more accurately. This may help doctors avoid unnecessary surgery and provide more personalized care for rectal cancer patients.
Eligibility 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).
Contact & Investigator
Ying-Chieh Lai, MD
PRINCIPAL INVESTIGATOR
Chang Gung Memorial Hospital, Link
Frequently Asked Questions
Who can join the NCT07730541 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Neoadjuvant Chemoradiotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07730541 currently recruiting?
Yes, NCT07730541 is actively recruiting participants. Contact the research team at cappolya@gmail.com for enrollment information.
Where is the NCT07730541 trial being conducted?
This trial is being conducted at Taoyuan, Taiwan.
Who is sponsoring the NCT07730541 clinical trial?
NCT07730541 is sponsored by Chang Gung Memorial Hospital. The principal investigator is Ying-Chieh Lai, MD at Chang Gung Memorial Hospital, Link. The trial plans to enroll 30 participants.