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Ovarian CarcinomaNCT03857087

68Ga-PSMA PET in Diagnosing Metastasis in Patients With Ovarian Cancer

An observational study of Ovarian Carcinoma, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Carcinoma
What is being tested?
Gallium Ga 68-labeled PSMA-11, Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET)
How many people
7 participants
Where
1 siteUnited States
Study dates
2 Apr 2018to 30 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: 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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: Gallium-68 Prostate Specific Membrane Antigen for Ovarian Cancer: A Pilot Feasibility Study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the feasibility and utility of 68Ga-PSMA PET imaging patients with ovarian cancer.

II. Determine detection sensitivity for nodal metastases for PSMA PET stratified by node size.

SECONDARY OBJECTIVES:

  1. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET and PSMA expression in surgical resection specimens.

EXPLORATORY OBJECTIVES:

  1. To explore heterogeneity of 68Ga-PSMA PET uptake in cases of metastatic ovarian cancer.

II. To determine the relationship between 68Ga-PSMA PET uptake, diffusion weighted imaging, and MRI-derived tumor perfusion.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. After about 60 minutes, patients undergo PET/magnetic resonance imaging (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.

After completion of study, patients are followed up at 28 days.

Being tested
Gallium Ga 68-labeled PSMA-11, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET)
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • Gallium Ga 68-labeled PSMA-11Drug

    Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC

    Given IV

  • Magnetic Resonance Imaging (MRI)Procedure or surgery

    Also called Magnetic Resonance Imaging, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI

    Given PET/MRI

  • Positron Emission Tomography (PET)Procedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography

    Undergo PET/MRI

Study groups in NCT03857087
Study groupRoleWhat they receive
Diagnostic 68Ga PSMA PET/MRIPatients 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.
Receives: Drug: Gallium Ga 68-labeled PSMA-11; Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET)

What is being measured

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

  1. 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.

    Measured: Study Visit Day 1

  2. 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.

    Measured: Study Visit Day 1

  3. Average maximum standard uptake value (SUVmax)

    The mean, range, and standard deviation of SUVmax across all visualized lesions per patient will be descriptively reported.

    Measured: Study Visit Day 1

  4. 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.

    Measured: Study Visit Day 1

  5. 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.

    Measured: Study Visit Day 1

Secondary outcomes (1)

  1. Correlation between targeted molecular uptake of 68Ga-PSMA PET and prostate-specific membrane antigen (PSMA) expression in surgical resection specimens

    For patients undergoing surgical resection, the 68Ga PSMA-PET uptake will be correlated with PSMA expression in the primary tumor as well as metastatic sites. PSMA expression measurement is available as a core service from the cancer center

    Measured: Study Visit Day 1

Timeline

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

  1. First posted27 Feb 2019
  2. Study start2 Apr 2018
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03857087
Sponsor's protocol ID
174017
Other IDs
NCI-2018-02331
Status last verified
Oct 2022
First submitted
26 Feb 2019
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Carcinoma, run by University of California, San Francisco 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 12 Oct 2022. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of gallium Ga 68-labeled PSMA-11 positron emission tomography (PET) positive lesions detected by standard staging scans (time frame: Study Visit Day 1). The study lists 5 primary outcomes in all. 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 NCT03857087, 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 12 Oct 2022.

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