Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404

99mTc MIP 1404

Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405

99mTc MIP 1405

Stanley J Goldsmith, MD

This is a single-blind, randomized, cross-over design. Patients with metastatic prostate adenocarcinoma; newly diagnosed, high-risk patients with prostate adenocarcinoma; and healthy subjects will be administered a single intravenous dose of each of the study drugs 99mTc MIP 1404 and 99mTc MIP 1405 administered approximately 14 to 21 days apart.

This trial is a single-blind, randomized, cross-over design. Up to six patients with confirmed metastatic prostate adenocarcinoma; six newly diagnosed, high-risk patients with prostate adenocarcinoma; and up to six healthy volunteers will receive 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 or 99mTc MIP 1405. Whole-body planar scintigraphic images will be acquired at various times post-injection over 24 hours. A pelvic SPECT/CT image will be acquired on the first day. Blood and urine will be collected for pharmacokinetic measurements and metabolic analysis over 24 hours. Each patient will receive an initial study drug administration and a second study drug administration approximately 14 to 21 days after the first. A final follow-up visit will occur approximately 2-3 weeks after the second study drug.

A Study of 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers

A Phase I Study of the PK, Tissue Distribution and Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen, 99mTc-MIP-1404 and 99mTc-MIP-1405, in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers

The safety data will be summarized for all patients receiving at least one dose of study drug. Summary tables, including change from pre dose to post dose where applicable, will be presented for the following safety endpoints:

* Treatment emergent adverse events
* Clinical Laboratory Evaluations
* Physical examination, vital signs, and ECGs

Standard PK parameters of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be calculated, including but not limited to: clearance, distribution half-life, elimination half-life, mean residence time and maximum concentration. These PK parameters will be listed by subject and summarized. Blood clearance and urinary recovery over time will be displayed in figures. Urine metabolites and impurities of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be listed by subject and summarized.

The PK population will be used in the analysis of pharmacokinetics and metabolism.

Percent of injected activity (%IA) in a set of source organs will be determined by comparing a reference whole body scan to subsequent whole body scans to determine percentage of administered activity for source organs at the various scanning times. This biodistribution data will then be used to mathematically model source organ residence times, which will be used to estimate radiation absorbed dose to target organs. Percent injected activity and estimated residence times will be summarized by organ.

To calculate the estimated radiation dosimetry to normal organs based on the pharmacokinetic and normal tissue distribution in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers

Molecular Insight Pharmaceuticals, Inc.

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404

A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404

Kevin Slawin, M.D.

This is a single arm, open label study of up to 24 prostate cancer patients scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer

A Phase 1 Pilot Comparison Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging to Histology in Men With Prostate Cancer

Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy

Summary tables will present change from pre-dose to post-dose vital signs measurements.

To obtain exploratory tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node

Evaluate the intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers	NCT01261754	Prostate Cancer	99mTc MIP 1404 99mTc MIP 1405	21 Years -	Molecular Insight Pharmaceuticals, Inc.
A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer	NCT01615406	Prostate Cancer	99mTc MIP 1404	21 Years -	Molecular Insight Pharmaceuticals, Inc.
A Study of 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers	NCT01261754	Prostate Cancer	99mTc MIP 1404 99mTc MIP 1405	21 Years -	Molecular Insight Pharmaceuticals, Inc.
A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer	NCT01615406	Prostate Cancer	99mTc MIP 1404	21 Years -	Molecular Insight Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for 99mtc mip 1404