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

Cervical Cancer Clinical Trial

Official title:

Precision Medicine Imaging for Cervical Cancer: Integrating MR Fingerprinting, Dynamic Nuclear Polarization (DNP)-MRI and Artificial Intelligence Radiomics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04951921
• Other study ID #: 201702080A0
• Status: Recruiting
• Phase: Phase 2
• Start date: July 15, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2023
• Source: Chang Gung Memorial Hospital
• Contact: Gigin Lin, MD, PhD
• Phone: 886-3-3281200
• Email: giginlin[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary objective

1. Bridging the Gap between Imaging and Biology. DNP is the only technology that can measure real-time flux of pyruvate to lactate conversion and mitochondria metabolism. DNP-MRI will combine the strength of MRI (anatomy, tissue contrast via MRF, CEST and DWI) and DNP (biochemistry measurement), and the blood/urine metabolomics approach, to noninvasively bring more insightful information for clinical application.

2. Precision Medicine for Precision Response Prediction. Although AI or deep learning can identify high-risk patient for particularly treatment (CCRT in this project), the predictive model is based on prior database rather than this particular patient. The investigators urgently need a non-invasive precise measurement to monitor the response in a real-world situation, to reduce the treatment uncertainty, to select the most cost-effective treatment. This is of paramount importance for the more advanced treatment i.e. target therapy, immunotherapy etc. The investigators did not intend to change the standard-of-care but the information provided by this study will help to investigate the fundamental mechanisms hence providing hopes for alternative treatments.

3. Infrastructures for MR Fingerprinting and Dynamic Nuclear Polarization (DNP)-MRI Research for Taiwanese researchers. The investigators are very grateful to be able to install the first DNP system dedicated to human research in Asia and would like to introduce this novel technology to Taiwan. Currently, human DNP study has only been conducted in the USA (UCSF, MD Anderson Cancer Center and Memorial Sloan-Kettering Cancer Center) and the UK (University College of London, Oxford and Cambridge) and Canada (Toronto University). Based on our preliminary efforts of tracer preparation, multi-nuclei scanning equipment and dedicated pulse sequences, the investigators aim to build infrastructures for MR Fingerprinting and DNP-MRI Research for Taiwanese research groups.

Secondary objective

1. Translate technical advancements to clinically applicable tools

2. Converge integrated information to construct the prediction model

3. Establish the delta radiomics prediction model with biological meaningfulness

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Hyperpolarized 13C Pyruvate
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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan City	Guishan District

Sponsors (2)

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

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI size measurement of the primary tumor	Tumor size measurement by regular MRI	Change from baseline in tumor size at 3 months
Secondary	Recurrent rate	Follow-up recurrent rate	Follow-up for 5 years