Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT03675451
Brief Summary:
The present study is a phase II, open label, single-center, non-randomized, single-dose study.
Twenty subjects in total will be enrolled at Weill Cornell Medical College (WCMC)/ NYPH.
The primary objective is to evaluate the ability of 89Zr-Df-IAB2M to detect localized, clinically significant (defined as: ≥ 0.5 cm3 with Gleason pattern ≥ 4) prostate cancer (PCa).
After the screening period (up to 28 days), each subject will be scheduled to receive 10 mg infusion of IAB2M conjugated with 2.5 mCi 89Zr-Df.
2 - 4 days post-infusion, subjects will undergo a 89Zr-Df-IAB2M PET/CT scan. Images read by a Nuc Med MD reporting: location, SUV and, if possible, size of all areas with abnormal uptake.
(they will also undergo a pelvic MRI if they have not obtained an MR image during the screening period or on day of infusion)
Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.
Patient will undergo radical prostatectomy after completion of above imaging procedures.
Detailed Description:
The primary endpoint of this study is the proportion of subjects with PSMA-positive (identified by H\&E staining and immunohistochemistry) "dominant" PC lesion(s) greater than 5mm in diameter, whose lesion(s) have been successfully identified by 89Zr-Df-IAB2M imaging. Because this is an exploratory pilot study, no formal sample size/power calculation is required. However, with a sample size of 20 patients in the study, a two-sided 95% confidence interval for the proportion of patients successfully imaged by 89Zr-Df-IAB2M can be constructed to be within ± 19.0% of the observed proportion of patients with successful imaging by 89Zr-Df-IAB2M. This calculation assumes an 89Zr-Df-IAB2M imaging-success proportion of 75%. All estimates from the study will serve as preliminary data (i.e., hypothesis-generating) for future studies.
Study:
NCT03675451
Study Brief:
Protocol Section:
NCT03675451