NCT04951921CompletedPhase 2
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 · Last updated 12 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 21 Jun 2021
- Start date
- 15 Jul 2021
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT04951921
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 6
- From 15 Jul 2021 to the primary completion date, 31 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Contraindication to MRI study (e.g. claustrophobia, cardiac pacemaker, metal implants in pelvis).
- 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.
Other
- Inadequate marrow, liver and renal functions.
- Pregnant or breast-feeding women.
Who the study is looking for
- Histologically confirmed carcinoma of the uterine cervix.
- Age ≥ 20 years.
- Clinical International Federation of Gynecology and Obstetrics (FIGO) stage IB2-IV.
- Tumor diameter ≥ 4 cm, verified by MRI or CT.
- Scheduled curative-intent non-surgical treatment.
Age in the registry: 20 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.