Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging

NCT05866679 | Suspended Phase 1 DMC FDA Drug

• 2 other identifiers: 2022-0395NCI-2023-03931
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03

  through study completion: an average of 5 years

Study Arms (1)

Hyperpolarized 13-C-pyruvate

EXPERIMENTAL

Drug: Hyperpolarized 13-C-pyruvate

Interventions

Hyperpolarized 13-C-pyruvate DRUG

Given by PO

Hyperpolarized 13-C-pyruvate

Eligibility Criteria

• Age: 18 Months+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For the first cohort, the following selection criteria will be applied who are undergoing a screening exam at MD Anderson:
• Patients with a first degree relative (mother, sister, or daughter) with ovarian cancer or
• A personal history of breast cancer before age 40 or
• 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
• Ashkenazi Jewish heritage and a personal history of breast cancer before age 50 or
• 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
• Presence of a BRCA1 or BRCA2 mutation or
• 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:
• patients who have suspicion of ovarian malignancy on conventional imaging and will be undergoing surgical resection will be included.

You may not qualify if:

• (all cohorts)
• \. Children, pregnant women, cognitively impaired adults, or prisoners will be excluded from participation.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Priya Bhosale, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: April 12, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)