Hyperpolarized 13C-MRI and Radiomics in Rectal Cancer

NCT07730541 | Recruiting DMC FDA Drug

• 2 other identifiers: DNP_RECA113-2314-B-182A-086
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoadjuvant Chemoradiotherapy

Keywords

Neoadjuvant Chemoradiotherapy; Rectal Cancer; Hyperpolarized 13C-MRI; Pyruvate

Outcome Measures

Primary Outcomes (1)

• Metabolic activity in spleen measured as pyruvate-to-lactate conversion rate

  The pyruvate-to-lactate conversion calculated by kinetic modeling-based conversion rate of pyruvate-to-lactate (kPL) and model-free metric (signal-to-noise ratio and area-under-curve).

  Data analysis within 7 days after HP 13C-MRI

Study Arms (2)

Pathological Complete Response (pCR)

Patients whose rectal cancer shows no residual tumor cells after neoadjuvant chemoradiotherapy, confirmed by pathology.

Drug: Hyperpolarized 13C-MRI (HP 13C-MRI)

Non-Complete Response (non-pCR)

Patients whose rectal cancer still shows residual tumor cells after neoadjuvant chemoradiotherapy, confirmed by pathology.

Drug: Hyperpolarized 13C-MRI (HP 13C-MRI)

Interventions

Hyperpolarized 13C-MRI (HP 13C-MRI) DRUG

Metabolic MRI using IV injection of hyperpolarized \[1-13C\]pyruvate.

Non-Complete Response (non-pCR); Pathological Complete Response (pCR)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with rectal cancer who received neoadjuvant chemoradiotherapy (nCRT) at a single center. Eligible participants are adults diagnosed with rectal cancer and treated with nCRT prior to surgery.

You may qualify if:

• Patients with biopsy proved rectal adenocarcinoma.
• Patents will undergo neoadjuvant chemoradiation therapy (nCRT).
• Patients more than 20-year-old.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial hospital

Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ying-Chieh Lai, MD

  Chang Gung Memorial Hospital, Link

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-Chieh Lai, MD

CONTACT

+88633281200; cappolya@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)