Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging

NCT ID: NCT05866679

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-12
• Study Completion Date: 2028-08-31

Brief Summary

To learn if an MRSI can be performed on a 3T scanner using an investigational contrast drug called hyperpolarized 13-C pyruvate. 3T refers to the "strength" of the MRI machine.

Detailed Description

Primary Objective:

1. To assess if increased lactate production measured by HP 13C MRI occurs in suspected ovarian cancer patients who will undergo surgery

2. To evaluate the proportion of increased lactate production in the ovaries measured by HP 13C MRI in low/high ovarian cancer risk patients.

Secondary Objectives:

1. Correlate HP-MR findings to metabolomics, immune profiles, and blood biomarkers of patients undergoing surgical resection.

2. Demonstrate the feasibility and utility of metabolic imaging with HP 13C pyruvate MR in patients with suspected ovarian cancer

3. Correlating imaging findings such as enhancement pattern, ADC values, and advanced image analytics such as texture with pathology and genetic analysis for patients who will undergo surgical resection.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Hyperpolarized 13-C-pyruvate

Group Type: EXPERIMENTAL

Hyperpolarized 13-C-pyruvate

Intervention Type: DRUG

Given by PO

Interventions

Hyperpolarized 13-C-pyruvate

Given by PO

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

For the first cohort, the following selection criteria will be applied who are undergoing a screening exam at MD Anderson:

1. Patients with a first degree relative (mother, sister, or daughter) with ovarian cancer or

2. A personal history of breast cancer before age 40 or

3. A personal history of breast cancer diagnosed before age 50, and one or more close relatives diagnosed with breast or ovarian cancer at any age. Two or more close relatives diagnosed with breast cancer before age 50 or with ovarian cancer diagnosed at any age or

4. Ashkenazi Jewish heritage and a personal history of breast cancer before age 50 or

5. Ashkenazi Jewish heritage and a first- or second-degree relative diagnosed with breast cancer before age 50 or with ovarian cancer at any age or

6. Presence of a BRCA1 or BRCA2 mutation or

7. Presence of a mismatch repair gene mutation associated with a hereditary cancer syndrome known as Hereditary Non-Polyposis Colon Cancer (HNPCC)/Lynch syndrome. For the second cohort- 10 Patients will be enrolled who present to MD Anderson for a pelvic ultrasound or have an outside ultrasound or imaging study without a mass or have an adnexal mass (benign) on outside imaging and do not have a high risk for ovarian cancer.

For the third cohort of patients:

10 patients who have suspicion of ovarian malignancy on conventional imaging and will be undergoing surgical resection will be included.

Exclusion Criteria

(all cohorts)

1. Children, pregnant women, cognitively impaired adults, or prisoners will be excluded from participation.

• Minimum Eligible Age: 18 Months
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Priya Bhosale, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2023-03931

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0395

Identifier Type: -

Identifier Source: org_study_id