NCT04951921

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

June 21, 2021

Last Update Submit

February 10, 2025

Conditions

Cervical Cancer

Keywords

Hyperpolarized 13C pyruvateDynamic nuclear polarizationArtificial intelligenceCervical cancerMagnetic resonance fingerprintingPrecision medicineRadiomics

Outcome Measures

Primary Outcomes (1)

  • MRI size measurement of the primary tumor

    Tumor size measurement by regular MRI

    Change from baseline in tumor size at 3 months

Secondary Outcomes (1)

  • Recurrent rate

    Follow-up for 5 years

Study Arms (1)

Hyperpolarized 13C pyruvate DNP-MRI scan

EXPERIMENTAL

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.

Drug: Hyperpolarized 13C Pyruvate

Interventions

Hyperpolarized 13C PyruvateDRUG

Procedure: Magnetic Resonance Imaging Undergo 1H-MRI of DWI/MRF/CEST for tumor cite following by 13C DNP-MRI for spleen for 3-5 minutes after hyperpolarized 13C pyruvate injection

Also known as: Hyperpolarized Carbon C 13 Pyruvate, Hyperpolarized Pyruvate (13C)
Hyperpolarized 13C pyruvate DNP-MRI scan

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Contraindication to MRI study (e.g. claustrophobia, cardiac pacemaker, metal implants in pelvis).
  • Inadequate marrow, liver and renal functions.
  • 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.
  • Pregnant or breast-feeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, Guishan District, 333, Taiwan

Location

Related Publications (1)

  • Lin 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: 38594558DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Gigin Lin, MD, PhD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 21, 2021

First Posted

July 7, 2021

Study Start

July 15, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)