Clinical trial · Interventional
Hyperpolarized 13C Pyruvate MRI for Early Immune Evaluation in Cervical Cancer Patients At Baseline and CCRT Therapy
Precision Medicine Imaging for Cervical Cancer: Integrating MR Fingerprinting, Dynamic Nuclear Polarization (DNP)-MRI and Artificial Intelligence Radiomics
- 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)
In this single armed, single-center, case-controlled study, the investigators will conduct a prospective trial and integrate the most advanced imaging technology to medical practice, attempting to solve the problem detected by radiomics approach. The investigators plan a 3-year project with non-randomized, single group assignment observational study design. Thirty participants with diagnosed LACC that are to receive CCRT are to be recruited for this prospective single institutional study from Chang Gung Memorial Hospital at Linkou (CGMH). Standard-of-care MRI/CT that is required for staging will be the first line screening method. A tumor biopsy and routine blood test will be obtained at the time of the initial clinic visit. Participants eligible for this study will receive two investigative exams-MRF, CEST, DNP-MRI MRI and Metabolomics, at baseline and the 2-week during CCRT. The new imaging methods being tested are MRF and CEST without contrast enhancement, and DNP-MRI which provides quantitative measurement of the metabolism occurring within cancer cells. It also involves injection of a contrast agent-Hyperpolarized pyruvate (13C) Injection. The participants will be injected with the study drug at a dose of 0.43 ml/kg and then receive MRI scan.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperpolarized 13C Pyruvate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperpolarized 13C pyruvate DNP-MRI scan
- description
- Patients receive hyperpolarized 13C pyruvate through IV injection less than 1-2 minute then undergo MRI over 3-5 minutes at baseline and 2 weeks after CCRT treatment. Total 2 times of MRI scan.
- interventionNames
- Drug: Hyperpolarized 13C Pyruvate
Primary outcomes (1)
- measure
- MRI size measurement of the primary tumor
- timeFrame
- Change from baseline in tumor size at 3 months
- description
- Tumor size measurement by regular MRI
Secondary outcomes (1)
- measure
- Recurrent rate
- timeFrame
- Follow-up for 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed carcinoma of the uterine cervix. 2. Age ≥ 20 years. 3. Clinical International Federation of Gynecology and Obstetrics (FIGO) stage IB2-IV. 4. Tumor diameter ≥ 4 cm, verified by MRI or CT. 5. Scheduled curative-intent non-surgical treatment. Exclusion Criteria: 1. Contraindication to MRI study (e.g. claustrophobia, cardiac pacemaker, metal implants in pelvis). 2. Inadequate marrow, liver and renal functions. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 4. Pregnant or breast-feeding women.
References
Publications (1)
- DERIVEDLin G, Hsieh CY, Lai YC, Wang CC, Lin Y, Lu KY, Chai WY, Chen AP, Yen TC, Ng SH, Lai CH. Hyperpolarized [1-13C]-pyruvate MRS evaluates immune potential and predicts response to radiotherapy in cervical cancer. Eur Radiol Exp. 2024 Apr 10;8(1):46. doi: 10.1186/s41747-024-00445-1. PMID 38594558