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Suspended
NCT05866679
Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging
Conditions: Ovarian Cancer
Sex: Female
Ages: 18 Months – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: M.D. Anderson Cancer Center
Location: M D Anderson Cancer Center Houston Texas
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.
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.
Source: ClinicalTrials.gov (NCT05866679). StuddyBuddy aggregates publicly available trial information.