Trial Outcomes & Findings for PSMA PET and MRI in Gynecological Cancers (NCT NCT03302156)

Results Overview

Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

up to 1 day

Results posted on

2023-09-05

Participant Flow

15 participants were consented from November 2017 to December 2019. Research was suspended in March 2020 per the COVID-19 pandemic. The study opened to enrollment again in June 2022; there were no more participants consented. The investigator terminated the study in January 2023 due to slow accrual of patients with ovarian cancer and due to lack of funding. No participants were enrolled in the Dosimetry group.

Participant milestones

Participant milestones
Measure	Healthy Control Non-Dosimetry Group The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer	Patient Group The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer
Overall Study STARTED	2	13
Overall Study Analysis Population	2	12
Overall Study Participants With Confirmed Ovarian Cancer With PSMA Uptake	0	1
Overall Study COMPLETED	2	12
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Control Non-Dosimetry Group The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer	Patient Group The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer	Dosimetry Group Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer
Overall Study no visible evidence of tumor on MRI	0	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Control Non-Dosimetry Group n=2 Participants The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer	Patient Group n=12 Participants The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer	Total n=14 Participants Total of all reporting groups
Age, Continuous	53.5 years n=2 Participants	57.3 years n=12 Participants	56.7 years n=14 Participants
Sex: Female, Male Female	2 Participants n=2 Participants	12 Participants n=12 Participants	14 Participants n=14 Participants
Sex: Female, Male Male	0 Participants n=2 Participants	0 Participants n=12 Participants	0 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	2 participants n=2 Participants	12 participants n=12 Participants	14 participants n=14 Participants
Suspected Participant Diagnosis Healthy Controls	2 Participants n=2 Participants	0 Participants n=12 Participants	2 Participants n=14 Participants
Suspected Participant Diagnosis Ovarian Cancer	0 Participants n=2 Participants	8 Participants n=12 Participants	8 Participants n=14 Participants
Suspected Participant Diagnosis Endometrial Cancer	0 Participants n=2 Participants	3 Participants n=12 Participants	3 Participants n=14 Participants
Suspected Participant Diagnosis Cervical Cancer	0 Participants n=2 Participants	0 Participants n=12 Participants	0 Participants n=14 Participants
Suspected Participant Diagnosis Other Cancer	0 Participants n=2 Participants	1 Participants n=12 Participants	1 Participants n=14 Participants

PRIMARY outcome

Timeframe: up to 1 day

Population: Calculating accuracy relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.

Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 1 day

Population: This was performed on the entire population of patients recruited in both the Healthy Control and Patient group.

Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.

Outcome measures

Outcome measures
Measure	Healthy Control Non-Dosimetry Group n=2 Participants The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer	Patient Group n=12 Participants The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer	Dosimetry Group Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer
Biodistribution of PSMA Measured by SUVmax in Normal Tissue Aorta at carina	2.0 SUVmax Standard Deviation 0.1	1.7 SUVmax Standard Deviation 0.5	—
Biodistribution of PSMA Measured by SUVmax in Normal Tissue Liver - Right Lobe	12.1 SUVmax Standard Deviation 5.4	10.0 SUVmax Standard Deviation 0.5	—
Biodistribution of PSMA Measured by SUVmax in Normal Tissue Myometrium	2.2 SUVmax Standard Deviation 0.4	2.9 SUVmax Standard Deviation 0.5	—
Biodistribution of PSMA Measured by SUVmax in Normal Tissue Endometrium	5.9 SUVmax Standard Deviation 1.8	4.8 SUVmax Standard Deviation 0.5	—
Biodistribution of PSMA Measured by SUVmax in Normal Tissue Cervix	4.0 SUVmax Standard Deviation 1.1	3.3 SUVmax Standard Deviation 0.5	—
Biodistribution of PSMA Measured by SUVmax in Normal Tissue Right Ovary	1.5 SUVmax Standard Deviation 1.7	3.0 SUVmax Standard Deviation 0.5	—
Biodistribution of PSMA Measured by SUVmax in Normal Tissue Corpus Luteum	6.3 SUVmax Standard Deviation NA Standard deviation was not calculated as only a single participant was analyzed	5.9 SUVmax Standard Deviation 0.5	—
Biodistribution of PSMA Measured by SUVmax in Normal Tissue Left Ovary	1.7 SUVmax Standard Deviation 1.4	2.3 SUVmax Standard Deviation 0.5	—

SECONDARY outcome

Timeframe: up to 1 day

Population: This was performed on the "Patient" population. There was only one patient with confirmed ovarian cancer with PSMA uptake.

Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.

Outcome measures

Outcome measures
Measure	Healthy Control Non-Dosimetry Group The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer	Patient Group n=1 Participants The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer	Dosimetry Group Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer
Biodistribution of PSMA Measured by SUVmax in Cancer Tissue	—	10.5 SUVmax Standard Deviation NA Standard deviation was not calculated as only a single participant was analyzed	—

SECONDARY outcome

Timeframe: up to 1 day

Population: No data was collected for this. There were no participants enrolled into the Dosimetry group. The study was terminated early due to low accrual and loss of funding.

The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 1 day

Population: Calculating sensitivity and specificity relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.

Record the distribution of PSMA in cancer tissue.

Outcome measures

Outcome data not reported

Adverse Events

Healthy Control Non-Dosimetry Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patient Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Sadowski, MD

UW School of Medicine and Public Health

Phone: 608-263-9028

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place