Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT01615406
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2012-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595576', 'term': '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)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'lastUpdateSubmitDate': '2015-11-23', 'studyFirstSubmitDate': '2012-06-04', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate', 'timeFrame': 'Within 3-6 hours of dosing SPECT/CT images will be taken', 'description': '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'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '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', 'description': 'Summary tables will present change from pre-dose to post-dose vital signs measurements.'}, {'measure': 'Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node', 'timeFrame': 'Within 3-6 hours of dosing SPECT/CT images will be taken', 'description': 'To obtain exploratory tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node'}, {'measure': 'Intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression', 'timeFrame': 'PSMA expression analysis will be conducted upon completion of enrollment', 'description': 'Evaluate the intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '9816319', 'type': 'BACKGROUND', '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.'}, {'pmid': '11016653', 'type': 'BACKGROUND', '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.'}, {'pmid': '14755683', 'type': 'BACKGROUND', '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.'}, {'pmid': '16555021', 'type': 'BACKGROUND', '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.'}, {'pmid': '9840525', 'type': 'BACKGROUND', '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.'}, {'pmid': '17290063', 'type': 'BACKGROUND', 'citation': 'Milowsky MI, Nanus DM, Kostakoglu L, Sheehan CE, Vallabhajosula S, Goldsmith SJ, Ross JS, Bander NH. Vascular targeted therapy with anti-prostate-specific membrane antigen monoclonal antibody J591 in advanced solid tumors. J Clin Oncol. 2007 Feb 10;25(5):540-7. doi: 10.1200/JCO.2006.07.8097.'}, {'pmid': '15809486', 'type': 'BACKGROUND', '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.'}, {'pmid': '19706750', 'type': 'BACKGROUND', 'citation': 'Hillier SM, Maresca KP, Femia FJ, Marquis JC, Foss CA, Nguyen N, Zimmerman CN, Barrett JA, Eckelman WC, Pomper MG, Joyal JL, Babich JW. Preclinical evaluation of novel glutamate-urea-lysine analogues that target prostate-specific membrane antigen as molecular imaging pharmaceuticals for prostate cancer. Cancer Res. 2009 Sep 1;69(17):6932-40. doi: 10.1158/0008-5472.CAN-09-1682. Epub 2009 Aug 25.'}, {'pmid': '18474004', 'type': 'BACKGROUND', '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.'}, {'pmid': '15840561', 'type': 'BACKGROUND', '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.'}, {'pmid': '15948673', 'type': 'BACKGROUND', '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.'}, {'pmid': '17685433', 'type': 'BACKGROUND', '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.'}, {'pmid': '9550550', 'type': 'BACKGROUND', '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.'}, {'pmid': '12938720', 'type': 'BACKGROUND', '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.'}, {'pmid': '15937315', 'type': 'BACKGROUND', '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.'}, {'pmid': '3882906', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male aged 21 years or older.\n* Ability to provide signed informed consent and willingness to comply with protocol requirements.\n* Past biopsy indicating the presence of adenocarcinoma of the prostate gland.\n* Participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection.\n* Have had, or will undergo diagnostic CT or MRI imaging prior to surgery.\n* 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.\n\nExclusion Criteria:\n\n* Participants for whom participating would significantly delay the scheduled standard of care therapy.\n* Participants administered a radioisotope within 5 physical half lives prior to study enrollment.\n* 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.'}, 'identificationModule': {'nctId': 'NCT01615406', 'briefTitle': 'A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Molecular Insight Pharmaceuticals, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MIP-1404-P105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: 99mTc-MIP-1404', 'description': '20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404', 'interventionNames': ['Drug: 99mTc MIP 1404']}], 'interventions': [{'name': '99mTc MIP 1404', 'type': 'DRUG', 'description': 'A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404', 'armGroupLabels': ['Drug: 99mTc-MIP-1404']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center - Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Kevin Slawin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanguard Urologic Research Foundation, University of Texas, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molecular Insight Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}