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

NCT01615406 | Completed Phase 1

• 1 other identifier: MIP-1404-P105
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate

  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

  Within 3-6 hours of dosing SPECT/CT images will be taken

Secondary Outcomes (3)

• Safety of 99mTc-MIP-1404 will be assessed by measuring Vital Signs (blood pressure and heart rate)Pre-Dose and Post-Dose as well as between 3-6 hours post-dose

  Vital signs measurements will be taken, an expected average of 30 minutes before and after study drug injection and between 3-6 hours after study drug injection

• Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node

  Within 3-6 hours of dosing SPECT/CT images will be taken

• Intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression

  PSMA expression analysis will be conducted upon completion of enrollment

Study Arms (1)

Drug: 99mTc-MIP-1404

EXPERIMENTAL

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

Drug: 99mTc MIP 1404

Interventions

99mTc MIP 1404 DRUG

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

Drug: 99mTc-MIP-1404

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male aged 21 years or older.
• Ability to provide signed informed consent and willingness to comply with protocol requirements.
• Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
• Participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection.
• Have had, or will undergo diagnostic CT or MRI imaging prior to surgery.
• Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after study drug administration, if engaged in sexual activity.

You may not qualify if:

• Participants for whom participating would significantly delay the scheduled standard of care therapy.
• Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
• Participants with any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.

Sponsors & Collaborators

• Molecular Insight Pharmaceuticals, Inc.: lead

Study Sites (1)

The University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

Related Publications (16)

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

technetium 99m 1-(1-(2-(bis(carboxymethyl)amino)-2-oxoethyl)-1H-imidazol-2-yl)-2-((1-(2-(bis(carboxymethyl)amino)-2-oxoethyl)-1H-imidazol-2-yl)methyl)-9,14-dioxo-2,8,13,15-tetraazaoctadecane-7,12,16,18-tetracarboxylic acid)

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kevin Slawin, M.D.

  Vanguard Urologic Research Foundation, University of Texas, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 8, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

US (1)