Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Hyperpolarized 13-C-pyruvate

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Priya Bhosale, MD; Phone Number: (713) 792-0221; Email: priya.bhosale@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Priya Bhosale, MD; Phone Number: 713-792-0221; Email: priya.bhosale@mdanderson.org
      • Principal Investigator: Priya Bhosale, Bhosale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperpolarized 13-C-pyruvate	Drug: Hyperpolarized 13-C-pyruvate; Given by PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Priya Bhosale, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Aberrant Motor Behavior in Dementia; Aggression; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: 2022-0395; NCI-2023-03931 (Other Identifier: NCI-Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No