Hyperpolarized 13C MRI for Cancer Immunotherapy

NCT05805358 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202201907A0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to develop an advanced imaging platform, such as dynamic nuclear polarization (DNP) 13C-MRI, MR fingerprinting (MRF) and MR Relaxometry, which combines with traditional anatomical contrast CT, MRI and PET, and integrate blood/urine metabolomics methods. A comprehensive strategy to thoroughly analyze the immune activation of spleen pattern, microstructure, cell density, red blood cell iron content, immune cell glycolysis and metabolic flow rate.

Conditions

Gynecologic Cancer; Cervical Cancer; Endometrial Cancer; Ovarian Cancer

Keywords

Carbon 13 pyruvate; Artificial intelligence; Ovarian Cancer; Cervical Cancer; Endometrial Cancer; Dynamic nuclear polarization; Magnetic resonance imaging; Computed tomography; Precision medicine; Metabolomics; Radiomics

Outcome Measures

Primary Outcomes (6)

• DNP conversion flux ( pyruvate-to-lactate conversion rate; Kpl) before immunotherapy

  To predict the response of immunotherapy

  ~1-2 weeks before clinical immunotherapies

• DNP conversion flux ( pyruvate-to-lactate conversion rate; Kpl) after immunotherapy

  To predict the response of immunotherapy

  Within 2 weeks after clinical immunotherapy

• DNP conversion flux (area under the curve; AUC) before immunotherapy

  To predict the response of immunotherapy

  ~1-2 weeks before clinical immunotherapy

• DNP conversion flux (area under the curve; AUC) after immunotherapy

  To predict the response of immunotherapy

  Within 2 weeks after clinical immunotherapy

• Clinical 18FDG PET standardized uptake values (SUV) before immunotherapy

  To predict the response of immunotherapy

  ~1 month before clinical immunotherapy

• Clinical 18FDG PET standardized uptake values (SUV) after immunotherapy

  To predict the response of immunotherapy

  ~2 months after clinical immunotherapy

Secondary Outcomes (3)

• MRI/CT size measurement of the primary tumor at the end of immunotherapy

  Up to 6 months

• Recurrent rate

  History tracking for half to five years

• Survival rate

  History tracking for half to five years

Study Arms (2)

Conventional Imaging Group

NO INTERVENTION

60 participants who accepted ICI treatment will receive conventional imaging

Next Generation Imaging Group

EXPERIMENTAL

30 participants who accepted ICI treatment will receive next generation imaging including MRF and MR Relaxometry and hyperpolarized 13C pyruvate DNP scanning.

Drug: Hyperpolarized 13C-Pyruvate injection

Interventions

Hyperpolarized 13C-Pyruvate injection DRUG

DNP-MRI for splenic immune function evaluation through hyperpolarized 13C-Pyruvate injection

Also known as: Hyperpolarized 1-13C Pyruvate injection, HP 13C-Pyruvate injection, Dynamic Nuclear Polarization

Next Generation Imaging Group

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Gynecological cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed or recurrent gynecological cancer confirmed by histology.
• Age ≥ 20 years old.
• Expected to receive immunotherapy.

You may not qualify if:

• Suffering from other malignancies (excluding non-melanoma skin cancer).
• History of splenic abnormalities (such as splenic damage, cirrhosis-related splenomegaly or primary/metastatic splenic tumors).
• Insufficient function of bone marrow, liver and kidney.
• Contraindications to MRI studies (e.g. claustrophobia, cardiac pacemaker, metal implants in the pelvis).
• Uncontrolled concurrent diseases, including but not limited to kidney stones, persistent or active infection, symptomatic heart failure, unstable angina, cardiac arrhythmias, or mental illness/social situations that limit compliance with research requirements.
• Pregnant or lactating women.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, Guishan District, 333, Taiwan

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Gigin Lin, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gigin Lin, MD, PhD

CONTACT

886-3-3281200; giginlin@cgmh.org.tw

Kuan-Ying Lu, MS

CONTACT

886-3-3281200; fantacy52317@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 10, 2023
• Study Start: November 1, 2023
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)