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Metabolic Imaging for Ovarian Cancer
Phase 1
Recruiting
Led By Priya Bhosale, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For the first cohort, patients with two or more close relatives diagnosed with breast cancer before age 50 or with ovarian cancer diagnosed at any age
For the first cohort, patients with a personal history of breast cancer before age 40
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion: an average of 5 years
Awards & highlights
Study Summary
This trial will test if an MRI machine's strength can be used to scan with an experimental drug to check for medical issues.
Who is the study for?
This trial is for adults at high risk of ovarian cancer due to family history, personal history of early breast cancer, BRCA1/2 or mismatch repair gene mutations. It's also for those with suspected ovarian malignancy on imaging. Excluded are children, pregnant women, cognitively impaired adults, and prisoners.Check my eligibility
What is being tested?
The study tests if an MRI scan using a special contrast drug called hyperpolarized 13-C pyruvate can assess the aggressiveness of ovarian tumors. The '3T' scanner strength indicates a powerful MRI machine used in this process.See study design
What are the potential side effects?
Potential side effects aren't detailed here but may include reactions to the investigational contrast drug such as discomfort at injection site or allergic reactions; however, MRIs generally do not have significant side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least two close relatives diagnosed with breast cancer before 50 or with ovarian cancer.
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I had breast cancer before I turned 40.
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I have a genetic mutation linked to Lynch syndrome.
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I was diagnosed with breast cancer before 50 and have a relative with breast or ovarian cancer.
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My mother, sister, or daughter has had ovarian cancer.
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I have a BRCA1 or BRCA2 mutation.
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I am of Ashkenazi Jewish heritage with a close relative who had breast cancer before 50 or ovarian cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion: an average of 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion: an average of 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hyperpolarized 13-C-pyruvateExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,446 Total Patients Enrolled
46 Trials studying Ovarian Cancer
16,715 Patients Enrolled for Ovarian Cancer
Priya Bhosale, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult.I have at least two close relatives diagnosed with breast cancer before 50 or with ovarian cancer.I had breast cancer before I turned 40.I am going to MD Anderson for a pelvic ultrasound or have had one without finding a mass, or have a benign mass and am not at high risk for ovarian cancer.I have a genetic mutation linked to Lynch syndrome.I am suspected to have ovarian cancer and will have surgery to remove it.I was diagnosed with breast cancer before 50 and have a relative with breast or ovarian cancer.My mother, sister, or daughter has had ovarian cancer.People with Ashkenazi Jewish heritage and a personal history of breast cancer before age 50 cannot participate in the first group of the study.I have a BRCA1 or BRCA2 mutation.I am of Ashkenazi Jewish heritage with a close relative who had breast cancer before 50 or ovarian cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Hyperpolarized 13-C-pyruvate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a current need for additional participants in this experiment?
"The data on clinicaltrials.gov shows that this medical trial is not actively recruiting patients. First posted in November 30th 2023, the project was last revised May 10th of the same year. However, there are 761 other trials searching for volunteers at present."
Answered by AI
Has the Federal Drug Administration accepted Hyperpolarized 13-C-pyruvate as a viable treatment option?
"Our assessment of Hyperpolarized 13-C-pyruvate's safety is a 1, as this clinical trial only has preliminary data to prove its efficacy and security."
Answered by AI
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