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Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging

Primary Purpose

Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized 13-C-pyruvate
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperpolarized 13-C-pyruvate

Arm Description

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
September 11, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05866679
Brief Title
Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging
Official Title
Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperpolarized 13-C-pyruvate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized 13-C-pyruvate
Intervention Description
Given by PO
Primary Outcome Measure Information:
Title
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
Time Frame
through study completion: an average of 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priya Bhosale, MD
Phone
(713) 792-0221
Email
priya.bhosale@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya Bhosale, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priya Bhosale, MD
Phone
713-792-0221
Email
priya.bhosale@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Priya Bhosale, Bhosale

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging

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