A Phase 1 interventional study of [124I] PSCA-Minibody PET/CT imaging of the whole body in Prostate Cancer, Pancreatic Cancer and Bladder Cancer, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-27.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 1, Interventional, and Diagnostic
The purpose of the study is to determine whether positron emission tomography (PET), using the new imaging drug [124 I] PSCA-Minibody can be used for imaging prostate, pancreatic or bladder cancer that has spread to the bones and soft tissues (e.g., lymph nodes, lungs, etc.). The PET imaging drug tested in this study binds to the cell marker called Prostate Stem Cell Antigen (PSCA), which is present on certain prostate, pancreatic and bladder cancers.
The people doing this study want to find out:
To answer these questions, we want to evaluate how [124 I] PSCA-Minibody is distributed throughout the body in 20 patients with prostate, pancreatic or bladder cancer. This is done with PET/CT imaging. A PET/CT scan is a non-invasive x-ray test that uses a special camera to take pictures of the inside of your body. It can "see" the radiation given off by tiny particles called positrons in the radioactive drug injected into you while also taking pictures of the organs within the body. For this study the radioactive substance is [124 I] PSCA-Minibody.
The scanning for this study is done with an imaging procedure in the department of Nuclear Medicine during which the experimental drug [124 I] PSCA-Minibody will be administered by intravenous (i.v.) infusion. An experimental drug is one that is not yet approved by the US Food and Drug Administration (FDA). [124 I] PSCA-Minibody is a combination of a monoclonal antibody, and I-124, a radioactive type of iodine. The iodine will make the antibody and the cancer cells visible in a PET scan. PET stands for positron emission tomography and uses radioactivity to image the inside of the body. A CT scan uses x-rays to look at the internal organs in the body. This study will use a combination PET/CT to look at the cancer cells in your body that have taken up the study agent as well as to see their location in your body.
3,236 studies on the registry are indexed under Pancreatic Neoplasms; 900 are open to participants now.
This study's enrollment of 8 is below the median of 46 across 2,425 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
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Inclusion Criteria (subjects must meet all of the following criteria in order to be enrolled in this study):
The following laboratory results should be within the following limits within 4 weeks prior to study day 1:
Exclusion Criteria (subjects meeting any of the following criteria will not be enrolled in this study):
Patients will receive one intravenous dose of 4 mg, 20mg or 40 mg of A11 minibody labeled with 5 mCi (185 MBq) of 124I, followed by \[124I\] PSCA-Minibody PET/CT imaging of the whole body.
Radiation: [124I] PSCA-Minibody PET/CT imaging of the whole body
Whole body Imaging
Assess the safety of [124I] PSCA-Minibody
Safety measures: adverse events including laboratory adverse events will be graded and summarized according to the National Cancer Institute CTCAE, version 4.03. * Laboratory tests (CBC with differential, platelets, serum electrolytes, BUN, creatinine, chemistry, urine analysis) * Vital signs (upright and supine blood pressure, heart rate, respiratory rate, oral temperature, and weight) * Physical examination * HAMBA tier in serum
Time frame: up to 3 months
Assess the ability of [124I] PSCA-Minibody to image known metastatic disease
Binary qualitative reading of \[124I\] PSCA-Minibody based PET imaging in subjects with known metastatic prostate, pancreatic, or bladder cancer to decide on the presence or absence of targeting to this cancer.
Time frame: 1 Day of scan
Compare the sensitivity and specificity of [124I] PSCA-Minibody with conventional imaging
Number, localization and size of metastatic lesions by 124I-A11 based PET/CT imaging and comparison to standard of care imaging with CT and bone scan.
Time frame: 1 Day of scan
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Jonsson Comprehensive Cancer Center