Hyperpolarized Carbon C13 Pyruvate with Magnetic Resonance Spectroscopy for the Detection of Ovarian Cancer and Assessment of Aggressiveness

Status: temporarily closed to accrual

This phase I trial evaluates the performance of an investigational contrast drug called hyperpolarized carbon C 13 pyruvate (HP 13C) used with magnetic resonance (MR) spectroscopy on a three tesla (3T) scanner for the detection of ovarian cancer as well as the assessment of aggressiveness. 3T refers to the "strength" of the magnetic resonance imaging (MRI) machine. Despite new surgical approaches and advances in chemotherapy, the 5-year survival rate for ovarian cancer has only improved from 33.7% to 46.2% in the last four decades. Unfortunately, there is no reliable early detection method, and due to the lack of symptoms at the early stages, ovarian cancer is usually not diagnosed until after the cancer has spread from where it first started (primary site) to other places in the body (metastasis) has occurred. The need for early detection methods is most acute in women at high risk for ovarian cancer, such as women who harbor BRCA (breast cancer gene) mutations or other risk factors, such as lynch syndrome, site-specific ovarian cancer syndrome, or family history of breast and ovarian cancer. Currently, ultrasound is used for screening patients who have a high risk of developing ovarian cancer. Ovarian tumor tissue has certain chemical differences from healthy tissue. MR spectroscopy is a MRI technique that can show these differences. MR spectroscopy uses the same scanner as a standard MRI. Unlike standard MRI, which takes pictures of the body, MR spectroscopy shows the chemical features of the ovarian tissue. Like routine MRI scans, MR spectroscopy scans can also involve contrast drugs (chemicals injected into the bloodstream to help the scanner “see” the tumor site better). HP 13C is a contrast agent naturally occurring and is non-radioactive. Using HP 13C with MR spectroscopy to assess normal and abnormal ovaries and ovarian masses may help find an imaging biomarker that is more sensitive and specific than the current gold standard, the ultrasound and conventional MRI. The information gained from this study could also help researchers learn if this scan can help doctors predict how aggressive a patient’s ovarian cancer may be.

Inclusion Criteria

FIRST COHORT: Patients with a first degree relative (mother, sister, or daughter) with ovarian cancer or
FIRST COHORT: A personal history of breast cancer before age 40 or
FIRST COHORT: 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
FIRST COHORT: Ashkenazi Jewish heritage and a personal history of breast cancer before age 50 or
FIRST COHORT: 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
FIRST COHORT: Presence of a BRCA1 or BRCA2 mutation or
FIRST COHORT: Presence of a mismatch repair gene mutation associated with a hereditary cancer syndrome known as Hereditary Non-Polyposis Colon Cancer (HNPCC)/Lynch syndrome
SECOND COHORT: Patients 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
THIRD COHORT: Patients who have suspicion of ovarian malignancy on conventional imaging and will be undergoing surgical resection will be included

Exclusion Criteria

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

PRIMARY OBJECTIVES:

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

II. 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:

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

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

III. Correlating imaging findings such as enhancement pattern, apparent diffusion coefficient (ADC) values, and advanced image analytics such as texture with pathology and genetic analysis for patients who will undergo surgical resection.

OUTLINE:

Patients receive HP 13C intravenously (IV) and undergo investigational MR spectroscopy before standard of care (SOC) MRI on study. Patients may receive an additional gadolinium-based contrast agent IV before SOC MRI on study.

After study completion, patients medical records are reviewed for up to 3 years.

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Hyperpolarized Carbon C13 Pyruvate with Magnetic Resonance Spectroscopy for the Detection of Ovarian Cancer and Assessment of Aggressiveness

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Hyperpolarized Carbon C13 Pyruvate with Magnetic Resonance Spectroscopy for the Detection of Ovarian Cancer and Assessment of Aggressiveness

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