Ovarian Cancer Clinical Trial

Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging

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.

View Full Description

Full Description

Primary Objective:

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

Correlate HP-MR findings to metabolomics, immune profiles, and blood biomarkers of patients undergoing surgical resection.
Demonstrate the feasibility and utility of metabolic imaging with HP 13C pyruvate MR in patients with suspected ovarian cancer
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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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:

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 is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05866679

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Priya Bhosale, MD
Contact
713-792-0221
[email protected]
Priya Bhosale, Bhosale
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05866679

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.