Who is sponsoring NCT01667536?

NCT01667536 is sponsored by Molecular Insight Pharmaceuticals, Inc..

What condition does NCT01667536 study?

NCT01667536 studies Prostate Cancer.

What drugs are being tested in NCT01667536?

Interventions: Drug: 99mTc-MIP-1404.

What is the status of NCT01667536?

NCT01667536 is currently COMPLETED.

Last reviewed 2016-12-14 · How we verify

A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

NCT01667536 Phase 2 COMPLETED Results posted

This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.

Details

Lead sponsor	Molecular Insight Pharmaceuticals, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	105
Start date	2012-08
Completion	2013-12

Conditions

Prostate Cancer

Interventions

Drug: 99mTc-MIP-1404

Primary outcomes

Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland. — Within 3-6 hours of dosing SPECT/CT images will be taken
For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.

Countries

United States, Belgium, Czechia, Hungary, Italy, Netherlands, Poland, Russia