Hyperpolarized 13C Pyruvate MRI for Early Immune Evaluation in Cervical Cancer Patients at Baseline and CCRT Therapy

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborator: Ministry of Science and Technology, Taiwan

Criteria

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.