68Ga-PSMA PET in Diagnosing Metastasis in Patients With Ovarian Cancer
Gallium-68 Prostate Specific Membrane Antigen for Ovarian Cancer: A Pilot Feasibility Study
2 other identifiers
observational
7
1 country
1
Brief Summary
This trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA) positron emission tomography (PET) works in patients with ovarian cancer to detect whether the tumor has spread to other places in the body. 68Ga-PSMA is a radioactive substance that binds to blood vessels around the ovarian cancer and can be imaged using PET. Diagnostic procedures, such as PET, may help find and diagnose find out how far the disease has spread.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2018
CompletedFirst Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedOctober 12, 2022
October 1, 2022
4.2 years
February 26, 2019
October 11, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Number of gallium Ga 68-labeled PSMA-11 positron emission tomography (PET) positive lesions detected by standard staging scans
Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging computed tomography/magnetic resonance imaging (CT/MRI). In addition, the mean, range, and standard deviation of standardized uptake value maximum (SUVmax) (across all visualized lesions per patient) and SUVmax-average (ave) (across all patients in the study cohort) will be descriptively reported.
Study Visit Day 1
Number of overall ovarian cancer lesions detected by standard staging scans
Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging CT/MRI.
Study Visit Day 1
Average maximum standard uptake value (SUVmax)
The mean, range, and standard deviation of SUVmax across all visualized lesions per patient will be descriptively reported.
Study Visit Day 1
Number of lymph nodes detected by PET
Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement.
Study Visit Day 1
Number of lymph nodes detected by MRI
Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement.
Study Visit Day 1
Secondary Outcomes (1)
Correlation between targeted molecular uptake of 68Ga-PSMA PET and prostate-specific membrane antigen (PSMA) expression in surgical resection specimens
Study Visit Day 1
Study Arms (1)
Diagnostic 68Ga PSMA PET/MRI
Patients receive gallium Ga 68-labeled PSMA-11 IV over 1-2 minutes. After about 60 minutes, patients undergo PET/MRI for approximately over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET between 8 and 12 weeks after completion of the first PET/MRI.
Interventions
Given IV
Given PET/MRI
Undergo PET/MRI
Eligibility Criteria
The patient population will be women with adnexal masses or other lesions suspicious for ovarian cancer metastases, who are scheduled for either resection or chemotherapy
You may qualify if:
- Patients with one of the following, identified on prior imaging (CT, MRI or Ultrasound):
- adnexal mass
- abdominal or pelvic tumor suspicious for ovarian cancer metastases (either suspected on clinical grounds, or known from prior tissue sampling)
- Female,
- Age \>= 18 years
- Creatinine \</= 1.5 mg/dL
- Ability to understand a written informed consent document, and the willingness to sign it
You may not qualify if:
- Pregnant or breastfeeding women
- Patient unlikely to comply with study procedure, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94115, United States
Related Publications (1)
Kunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18.
PMID: 36512649DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Ohliger, MD, PhD
University of California, San Francisco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 26, 2019
First Posted
February 27, 2019
Study Start
April 2, 2018
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share