Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer (IAB2M)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01923727|
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : August 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Cancer||Radiation: [89Zr]Df-IAB2M||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional).
A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg, 20mg or 50mg.
- Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer. [ Time Frame: Day 1 (Infusion Day) through Day 7 ]To assess the safety of a single dose of of [89Zr]Df-IAB2M
- [89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer [ Time Frame: Day 1 (Infusion Day) to Day 3 ]To determine the ability of 89Zr-Df-IAb2M PET to detect known sites of disease in patients with metastatic prostate cancer
- Optimal parameters for imaging with [89Zr]Df-IAB2M [ Time Frame: Day 1 (Infusion Day) to Day 3 ]To evaluate the mass dose and hours post infusion that provides optimal detection of metastatic prostate cancer
- Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer [ Time Frame: Up to 4 weeks ]To compare the results of the biopsy and FDG PET scan to the [89Zr]Df-IAB2M images
- Determine the radiation dose levels from a single infusion of [89Zr]Df-IAB2M in individuals with metastatic prostate cancer [ Time Frame: Day 1 (Infusion Visit) to Day 3 ]Evaluate the biodistribution of [89Zr]Df-IAB2M with PET/CT scans, whole body counts and blood samples to determine the radiation dose to organs in individuals with metastatic prostate cancer.
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): NCT01923727
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Neeta Pandit-Taskar, MD||Memorial Sloan Kettering Cancer Center|