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

NCT01654874 | Completed Phase 1

• 1 other identifier: MIP-TcTx-P101b
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (1)

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

  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.

Study Arms (2)

Preparation A

EXPERIMENTAL

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

Drug: 99mTc-MIP-1404

Preparation B

EXPERIMENTAL

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

Drug: 99mTc-MIP-1404

Interventions

99mTc-MIP-1404 DRUG

Preparation A; Preparation B

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: Yes
• 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.
• 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.
• 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
• PSA laboratory assessment within normal range (PSA \< 4 ng/ml)
• Normal findings on a digital rectal examination
• Hemoglobin and hematocrit within normal range

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Molecular Insight Pharmaceuticals, Inc.: lead

Study Sites (1)

New York Presbyterian Hospital, Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (14)

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• 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.

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• 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.

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• 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.

  PMID: 9840525 BACKGROUND

• 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.

  PMID: 15809486 BACKGROUND

• 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.

  PMID: 18474004 BACKGROUND

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• 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.

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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

• Stanley J Goldsmith, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2013
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

US (1)