99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
NCT ID: NCT04857502
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2021-04-27
2027-06-01
Brief Summary
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Detailed Description
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I. To define the biodistribution of 99mTc-based PSMA imaging and surgery agent (99mTc-PSMA-I\&S) in normal and malignant tissues of patients with prostate cancer (PCa) with histopathology validation, when available.
SECONDARY OBJECTIVES:
I. To correlate the 99mTc-PSMA-I\&S accumulation within tumor lesions observed by in-vivo single-photon emission computed tomography (SPECT), ex-vivo gamma measurements and level of prostate-specific membrane antigen (PSMA) expression quantified by histopathology, when available.
II. To define the best time-point for radio-guided surgery (RGS) with the highest tumor-to-background ratio following 99mTc-PSMA-I\&S administration.
OUTLINE:
The first 5 patients receive an initial dose of 99mTc-PSMA-I\&S intravenously (IV) followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I\&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I\&S IV before surgery.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Diagnostic (99mTc-PSMA-I&S, SPECT/CT)
The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I\&S IV followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I\&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I\&S IV before standard of care surgery.
99mTc-based PSMA Imaging and Surgery Agent
Given via IV injection
Computed Tomography
Undergo SPECT/CT
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Interventions
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99mTc-based PSMA Imaging and Surgery Agent
Given via IV injection
Computed Tomography
Undergo SPECT/CT
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
* Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
* Men who are scheduled for pelvic LN dissection (PLND)
* Men who can provide oral and written informed consent
* Men who can comply with study procedures
Exclusion Criteria
* Technically inaccessible nodal location
MALE
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jeremie Calais, MD
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2021-01793
Identifier Type: REGISTRY
Identifier Source: secondary_id
20-002256
Identifier Type: -
Identifier Source: org_study_id
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