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| ID | Type | Description | Link |
|---|---|---|---|
| MNBD-PROT01 | Other Identifier | Jonsson Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| ImaginAb, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [124I] PSCA-Minibody PET/CT imaging of the whole body | Radiation | Whole body Imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 Day of scan |
| Compare the sensitivity and specificity of [124I] PSCA-Minibody with conventional imaging |
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Inclusion Criteria (subjects must meet all of the following criteria in order to be enrolled in this study):
Histological diagnosis of prostate, bladder or pancreatic cancer.
Evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI, or FDG-PET within 6 weeks (with no new interval treatment before imaging trial)
Expected survival ≤ 6 months
Provide written informed consent and willing to comply with protocol requirement
≥ 18 years of age
The following laboratory results should be within the following limits within 4 weeks prior to study day 1:
Able to undergo imaging studies, as well as conventional bone and body imaging, as well as 124I-A11 PSCA minibody experimental scan.
Exclusion Criteria (subjects meeting any of the following criteria will not be enrolled in this study):
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| Name | Affiliation | Role |
|---|---|---|
| Alan Pantuck, MD | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90024 | United States |
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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. |
| 1 Day of scan |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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