NCT03619655

Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.

Detailed description

The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT. The study will consist of 3 cohorts, and a subset of the patients in cohort C will participate in a test-retest study, where the baseline SPECT/CT will be repeated. SPECT CT will be performed in all cohorts. Cohort A will evaluate SPECT CT by comparison to a Positron Emission Tomography (PET) scan using NaF. Cohort B will evaluate SPECT CT by comparison to 18F-DCFPyL PET/CT. Cohort C will evaluate SPECT CT by comparison to Whole Body Magnetic Resonance Imaging (WB-MRI). Eligible subjects will be enrolled in a non-randomized manner per the treating physician discretion.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	SPECT CT	MDP (99mTc-MDP) administration, about 180 min post-injection: whole body scan followed by a SPECT CT of regions designated by a board certified Nuclear Medicine physician after review of the whole body scan.
DRUG	18F-DCFPyL PET/CT	A bolus of \~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.
DRUG	18F-NaF PET/CT	A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose. At the 1 hour post injection time, total Whole Body Images take approximately 40 - 60 minutes depending on the height of the patient.
PROCEDURE	WB-MRI	Whole body MRI exam (total examination time \< 50 minutes)

Timeline

• Start date: 2019-11-15
• Primary completion: 2022-11-14
• Completion: 2022-11-14
• First posted: 2018-08-08
• Last updated: 2023-10-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study