Gynecologic CancerPhase 2NCT03302156

PSMA PET and MRI in Gynecological Cancers

A Phase 2 study testing PSMA-based 18F-DCFPyL PET tracer in people with Gynecologic Cancer, run by University of Wisconsin, Madison at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The goal of this research is to determine the accuracy of PSMA positron emission tomography (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of gynecological cancer cells in the body. Read more about this study

Who is it for?: Ages 18 to 99 years, women onlyHealthy volunteers can take part
Conditions the study is for: Gynecologic Cancer
What is being tested?: PSMA-based 18F-DCFPyL PET tracer
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2017to 20 Jan 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Women with or without suspected gynecological cancer.
No contraindications for MR or PET imaging.
Greater than or equal to 18 years of age.
Inclusion Criteria for gynecological cancer patients (N=40):
Women with known or suspected gynecological cancer
No contraindications for MR or PET imaging.
Greater than or equal to 18 years
Have had or are scheduled to undergo a hysterectomy and/or salpingo-oophorectomy

Who cannot join

Women that are pregnant or breast-feeding.
Age <18
Inability to provide informed consent on their own behalf
Severe kidney dysfunction (GFR <30 mL/min/1.73m2)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin, Madison
Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers

Read the detailed description

The investigators will evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, to determine the presence or absence of cancer, the accurate distribution of cancer and the normal biodistribution of PSMA in the abdomen and pelvis on PET imaging.

PSMA, also known as folate hydrolase 1 and glutamate carboxypeptidase II, is an enzyme associated with prostate cancer but has been also found to be expressed in the tumor neovasculature of many different types of non-prostate cancer tumors. PSMA-based 18F-DCFPyL PET demonstrates very high tumor-to-background ratio when studied in other tumors, including prostate tumors.

MR imaging is a highly sensitive and specific imaging modality that can be used for gynecologic cancers. MR images can be obtained in conjunction with PSMA PET, adding additional anatomic and multi-parametric MRI information without the need for a second imaging appointment.

Conditions: Gynecologic Cancer
Being tested: PSMA-based 18F-DCFPyL PET tracer
Keywords: Uterine cancer, Ovarian cancer, Hysterectomy, Salpingo-oophorectomy
Medical subject headings: Uterine Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PSMA-based 18F-DCFPyL PET tracerDrug
Also called PSMA
PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer

Study groups in NCT03302156
Study group	Role	What they receive
Healthy Control Non-Dosimetry Group	Other	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 Receives: Drug: PSMA-based 18F-DCFPyL PET tracer
Patient Group	Other	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 Receives: Drug: PSMA-based 18F-DCFPyL PET tracer
Dosimetry Group	Other	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 Receives: Drug: PSMA-based 18F-DCFPyL PET tracer

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic Accuracy
Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.
Measured: up to 1 day

Secondary outcomes (4)

Biodistribution of PSMA Measured by SUVmax in Normal Tissue
Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.
Measured: up to 1 day
Biodistribution of PSMA Measured by SUVmax in Cancer Tissue
Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.
Measured: up to 1 day
Radiodosimetry of PSMA
The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.
Measured: up to 1 day
Sensitivity and Specificity of PSMA-based PET/MR
Record the distribution of PSMA in cancer tissue.
Measured: up to 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201720 Jan 2020

First posted4 Oct 2017
Study start15 Nov 2017
Primary completion20 Jan 2020
Study completion20 Jan 2020

Why it stopped: Slow accrual following suspension per COVID-19

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gynecologic CancerStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03302156
Sponsor's protocol ID: UW17017
Other IDs: 2017-0456, A539300, SMPH\RADIOLOGY\RADIOLOGY, NCI-2018-00466, 06-08-2020
Status last verified: Jul 2023
First submitted: 18 Aug 2017
Last updated: 5 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 36512649

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
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Enrolling by invitation
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RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
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All Gynecologic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers
ClinicalTrials.gov ID: NCT03302156
Acronym / sponsor ID: UW17017
Conditions: Gynecologic Cancer
Keywords: Uterine cancer, Ovarian cancer, Hysterectomy, Salpingo-oophorectomy
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow accrual following suspension per COVID-19
Enrolment: 15 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: 15 Nov 2017 (actual)
Primary completion: 20 Jan 2020 (actual)
Study completion: 20 Jan 2020 (actual)
First posted: 4 Oct 2017 (actual)
Results: Posted 9 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Healthy Control Non-Dosimetry Group	Other	Drug: PSMA-based 18F-DCFPyL PET tracerThe 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
Patient Group	Other	Drug: PSMA-based 18F-DCFPyL PET tracerThe 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
Dosimetry Group	Other	Drug: PSMA-based 18F-DCFPyL PET tracerWomen 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

Who may qualify

Ages: 18 to 99 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Women with or without suspected gynecological cancer.
No contraindications for MR or PET imaging.
Greater than or equal to 18 years of age.
Women with known or suspected gynecological cancer
No contraindications for MR or PET imaging.

Key exclusion criteria (4 listed)

Women that are pregnant or breast-feeding.
Age <18
Inability to provide informed consent on their own behalf
Severe kidney dysfunction (GFR <30 mL/min/1.73m2)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PSMA-based 18F-DCFPyL PET tracerAlso: PSMAPSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer	Drug	Dosimetry Group, Healthy Control Non-Dosimetry Group, Patient Group

Primary outcome

Diagnostic Accuracy
Time frame: up to 1 day
Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.

4 secondary outcomes

Biodistribution of PSMA Measured by SUVmax in Normal Tissue
Time frame: up to 1 day
Biodistribution of PSMA Measured by SUVmax in Cancer Tissue
Time frame: up to 1 day
Radiodosimetry of PSMA
Time frame: up to 1 day
Sensitivity and Specificity of PSMA-based PET/MR
Time frame: up to 1 day

Results and safety

Results posted to the registry on 9 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Control Non-Dosimetry Group	2	2
Patient Group	13	12
Dosimetry Group	0	0

Primary outcome: Diagnostic Accuracy

Time frame: up to 1 day

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: during research visit, up to 3 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Control Non-Dosimetry Group	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Patient Group	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): Calculating accuracy, 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36512649Kunikowska 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.
University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.

Related trials for Gynecologic Cancer

RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
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Not yet recruiting
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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steve Cho, MD principal investigator

University of Wisconsin, Madison

Elizabeth Sadowski, MD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PSMA-based 18F-DCFPyL PET tracer in people with Gynecologic Cancer, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Accuracy (time frame: up to 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03302156, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.