To hear about similar clinical trials, please enter your email below
Trial Title:
Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging
NCT ID:
NCT05866679
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Aggression
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hyperpolarized 13-C-pyruvate
Description:
Given by PO
Arm group label:
Hyperpolarized 13-C-pyruvate
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.
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Months
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Priya Bhosale, MD
Phone:
713-792-0221
Email:
priya.bhosale@mdanderson.org
Investigator:
Last name:
Priya Bhosale, Bhosale
Email:
Principal Investigator
Start date:
April 12, 2024
Completion date:
August 31, 2028
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05866679
http://www.mdanderson.org
