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

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ClinicalTrials.gov Identifier: NCT03857087
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Drug: Gallium Ga 68-labeled PSMA-11 Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

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

EXPLORATORY OBJECTIVES:

I. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gallium-68 Prostate Specific Membrane Antigen for Ovarian Cancer: A Pilot Feasibility Study
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Gallium

Arm Intervention/treatment
Experimental: 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.
Drug: Gallium Ga 68-labeled PSMA-11
Given IV
Other Names:
  • (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
  • 68Ga-HBED-CC-PSMA
  • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • 68Ga-PSMA-11
  • [68Ga] Prostate-specific Membrane Antigen 11
  • [68Ga]GaPSMA-11
  • Ga-68 labeled PSMA-11
  • Gallium Ga 68 PSMA-11
  • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • PSMA-HBED-CC GA-68

Procedure: Magnetic Resonance Imaging
Given PET/MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Positron Emission Tomography
Undergo PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. 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 ]
    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.

  2. Number of overall ovarian cancer lesions detected by standard staging scans [ Time Frame: Study Visit Day 1 ]
    Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging CT/MRI. In addition, the mean, range, and standard deviation of SUVmax (across all visualized lesions per patient) and SUVmax-ave (across all patients in the study cohort) will be descriptively reported.

  3. Number of lymph nodes detected by PET [ Time Frame: Study Visit Day 1 ]
    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.

  4. Number of lymph nodes detected by MRI [ Time Frame: Study Visit Day 1 ]
    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.


Secondary Outcome Measures :
  1. Targeted molecular uptake of Ga 68-labeled PSMA-11 PET [ Time Frame: Study Visit Day 1 ]
    The 68Ga PSMA-PET uptake will be correlated with prostate-specific membrane antigen expression in the primary tumor as well as metastatic sites.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with suspected or pathologically diagnosed ovarian cancer
  • Measurable disease on prior imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) without interval debulking or treatment
  • Creatinine =< 1.5 mg/dL
  • Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

  • Patients with or with a history of uncontrolled bleeding diathesis
  • Patients who have had active infection within 15 days of study enrollment
  • Pregnant or breastfeeding women
  • Patients with an inability to access an intravenous line

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857087


Contacts
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Contact: Kimberly Silverio (415) 514-6725 Kimberly.Silverio@ucsf.edu

Locations
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United States, California
UCSF Medical Center-Mount Zion Recruiting
San Francisco, California, United States, 94115
Contact: Michael Ohliger    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Michael Ohliger         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Michael Ohliger UCSF Medical Center-Mount Zion

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Responsible Party: Thomas Hope, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03857087     History of Changes
Other Study ID Numbers: 174017
NCI-2018-02331 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Edetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents