Back to results

99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

99mTc-MIP-1404

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male aged 21 years or older.
Ability to provide signed informed consent and willingness to comply with protocol requirements.
Participants must agree to use an acceptable form of birth control throughout the study period. Participants must agree to use condoms for a period of seven days after each study drug administration, if engaged in sexual activity.

Additional Inclusion Criteria for Metastatic Prostate Adenocarcinoma Patients:

Histologic diagnosis of prostate cancer by validated medical history (pathology report, if available).
Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT scan, or MRI
Karnofsky performance is ≥ 60

Additional Inclusion Criteria for Healthy Volunteers:

PSA laboratory assessment within normal range (PSA < 4 ng/ml)
Normal findings on a digital rectal examination
Hemoglobin and hematocrit within normal range

Exclusion Criteria:

Received a radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
Participant is determined by the Investigator to be clinically unsuitable for the study
Serum creatinine ≥ 2.0 mg/dl
Total bilirubin ≥ 2.0 mg/dl
Liver transaminases ≥ 1.5 x ULN
Platelet count < 100,000/mm3
Absolute neutrophil count (ANC) < 2,000/mm3
Hematocrit < 30% or hemoglobin < 10 g/dl

Additional Exclusion Criteria for Metastatic Prostate Adenocarcinoma Patients:

Have received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants; or 12 months for 125I implants
Have had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, in which the diagnosis and location have not been defined as clinically controlled or treated to complete response

Sites / Locations

New York Presbyterian Hospital, Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Preparation A

Preparation B

Arm Description

20 (±3) mCi 99mTc-MIP-1404 (preparation A)

20 (±3) mCi 99mTc-MIP-1404 (preparation B)

Outcomes

Primary Outcome Measures

To assess the image quality of a simplified kit formulation of 99mTc-MIP-1404 (study drug) compared to a multi-step preparation of 99mTc-MIP-1404 in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers

Secondary Outcome Measures

To determine the pharmacokinetics, biodistribution and tumor uptake of 99mTc-MIP-1404 preparations in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers

Full Information

NCT ID

NCT01654874

First Posted

July 30, 2012

Last Updated

November 23, 2015

Sponsor

Molecular Insight Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01654874

Brief Title

99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404

Official Title

99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Molecular Insight Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is a single-blind, cross-over design. Up to three patients with confirmed metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation B). Whole-body planar scintigraphic images will be acquired at various time points on the day of study drug administration. A pelvic SPECT/CT image will be acquired on the day of study drug administration. Blood will be collected for pharmacokinetic measurements following study drug administration. Each participant will receive an initial study drug administration (preparation A) and a second study drug administration (preparation B) approximately 7 to 21 days later. A final follow-up visit will occur approximately 2 - 3 weeks after the second study drug administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Preparation A

Arm Type

Experimental

Arm Description

20 (±3) mCi 99mTc-MIP-1404 (preparation A)

Arm Title

Preparation B

Arm Type

Experimental

Arm Description

20 (±3) mCi 99mTc-MIP-1404 (preparation B)

Intervention Type

Drug

Intervention Name(s)

99mTc-MIP-1404

Primary Outcome Measure Information:

Title

Time Frame

Whole-body planar scintigraphic images will be acquired at 30 min, 2 and 4 hours post administration. A pelvic SPECT/CT image will be acquired at 3 hours post study drug administration

Secondary Outcome Measure Information:

Title

To determine the pharmacokinetics, biodistribution and tumor uptake of 99mTc-MIP-1404 preparations in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers

Time Frame

Blood will be collected for PK and radioactivity counting at baseline, 2 minutes, 5 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours post study drug administration.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male aged 21 years or older. Ability to provide signed informed consent and willingness to comply with protocol requirements. Participants must agree to use an acceptable form of birth control throughout the study period. Participants must agree to use condoms for a period of seven days after each study drug administration, if engaged in sexual activity. Additional Inclusion Criteria for Metastatic Prostate Adenocarcinoma Patients: Histologic diagnosis of prostate cancer by validated medical history (pathology report, if available). Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT scan, or MRI Karnofsky performance is ≥ 60 Additional Inclusion Criteria for Healthy Volunteers: PSA laboratory assessment within normal range (PSA < 4 ng/ml) Normal findings on a digital rectal examination Hemoglobin and hematocrit within normal range Exclusion Criteria: Received a radioisotope within 5 physical half lives of that radioisotope prior to study enrollment Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations Participant is determined by the Investigator to be clinically unsuitable for the study Serum creatinine ≥ 2.0 mg/dl Total bilirubin ≥ 2.0 mg/dl Liver transaminases ≥ 1.5 x ULN Platelet count < 100,000/mm3 Absolute neutrophil count (ANC) < 2,000/mm3 Hematocrit < 30% or hemoglobin < 10 g/dl Additional Exclusion Criteria for Metastatic Prostate Adenocarcinoma Patients: Have received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants; or 12 months for 125I implants Have had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, in which the diagnosis and location have not been defined as clinically controlled or treated to complete response

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stanley J Goldsmith, MD

Organizational Affiliation

Department of Nuclear Medicine, New York Presbyterian Hospital, Weill Cornell Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York Presbyterian Hospital, Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

9816319

Citation

Pinto JT, Suffoletto BP, Berzin TM, Qiao CH, Lin S, Tong WP, May F, Mukherjee B, Heston WD. Prostate-specific membrane antigen: a novel folate hydrolase in human prostatic carcinoma cells. Clin Cancer Res. 1996 Sep;2(9):1445-51.

Results Reference

background

PubMed Identifier

11016653

Citation

Smith-Jones PM, Vallabahajosula S, Goldsmith SJ, Navarro V, Hunter CJ, Bastidas D, Bander NH. In vitro characterization of radiolabeled monoclonal antibodies specific for the extracellular domain of prostate-specific membrane antigen. Cancer Res. 2000 Sep 15;60(18):5237-43.

Results Reference

background

PubMed Identifier

14755683

Citation

Ghosh A, Heston WD. Tumor target prostate specific membrane antigen (PSMA) and its regulation in prostate cancer. J Cell Biochem. 2004 Feb 15;91(3):528-39. doi: 10.1002/jcb.10661.

Results Reference

background

PubMed Identifier

16555021

Citation

Kinoshita Y, Kuratsukuri K, Landas S, Imaida K, Rovito PM Jr, Wang CY, Haas GP. Expression of prostate-specific membrane antigen in normal and malignant human tissues. World J Surg. 2006 Apr;30(4):628-36. doi: 10.1007/s00268-005-0544-5.

Results Reference

background

PubMed Identifier

9840525

Citation

Murphy GP, Elgamal AA, Su SL, Bostwick DG, Holmes EH. Current evaluation of the tissue localization and diagnostic utility of prostate specific membrane antigen. Cancer. 1998 Dec 1;83(11):2259-69.

Results Reference

background

PubMed Identifier

15809486

Citation

Vallabhajosula S, Kuji I, Hamacher KA, Konishi S, Kostakoglu L, Kothari PA, Milowski MI, Nanus DM, Bander NH, Goldsmith SJ. Pharmacokinetics and biodistribution of 111In- and 177Lu-labeled J591 antibody specific for prostate-specific membrane antigen: prediction of 90Y-J591 radiation dosimetry based on 111In or 177Lu? J Nucl Med. 2005 Apr;46(4):634-41.

Results Reference

background

PubMed Identifier

18474004

Citation

Olson WC, Heston WD, Rajasekaran AK. Clinical trials of cancer therapies targeting prostate-specific membrane antigen. Rev Recent Clin Trials. 2007 Sep;2(3):182-90. doi: 10.2174/157488707781662724.

Results Reference

background

PubMed Identifier

15840561

Citation

Rajasekaran AK, Anilkumar G, Christiansen JJ. Is prostate-specific membrane antigen a multifunctional protein? Am J Physiol Cell Physiol. 2005 May;288(5):C975-81. doi: 10.1152/ajpcell.00506.2004.

Results Reference

background

PubMed Identifier

15948673

Citation

Slovin SF. Targeting novel antigens for prostate cancer treatment: focus on prostate-specific membrane antigen. Expert Opin Ther Targets. 2005 Jun;9(3):561-70. doi: 10.1517/14728222.9.3.561.

Results Reference

background

PubMed Identifier

17685433

Citation

Wang X, Yin L, Rao P, Stein R, Harsch KM, Lee Z, Heston WD. Targeted treatment of prostate cancer. J Cell Biochem. 2007 Oct 15;102(3):571-9. doi: 10.1002/jcb.21491.

Results Reference

background

PubMed Identifier

9550550

Citation

Barrett PH, Bell BM, Cobelli C, Golde H, Schumitzky A, Vicini P, Foster DM. SAAM II: Simulation, Analysis, and Modeling Software for tracer and pharmacokinetic studies. Metabolism. 1998 Apr;47(4):484-92. doi: 10.1016/s0026-0495(98)90064-6.

Results Reference

background

PubMed Identifier

12938720

Citation

Stabin MG, Siegel JA. Physical models and dose factors for use in internal dose assessment. Health Phys. 2003 Sep;85(3):294-310. doi: 10.1097/00004032-200309000-00006.

Results Reference

background

PubMed Identifier

15937315

Citation

Stabin MG, Sparks RB, Crowe E. OLINDA/EXM: the second-generation personal computer software for internal dose assessment in nuclear medicine. J Nucl Med. 2005 Jun;46(6):1023-7.

Results Reference

background

PubMed Identifier

3882906

Citation

Pan ZY, Wolf W. Computer package for the calculation of the radiation dose to patients, based on the MIRD approach. J Nucl Med. 1985 Mar;26(3):318-20. No abstract available.

Results Reference

background

Learn more about this trial

99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404

We'll reach out to this number within 24 hrs