Clinical trial · Interventional
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
NCT01615406CI-TRIAL-00019942completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTc MIP 1404 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Drug: 99mTc-MIP-1404
- description
- 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404
- interventionNames
- Drug: 99mTc MIP 1404
Primary outcomes (1)
- 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
Secondary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (16)
- BACKGROUNDPinto 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 9816319
- BACKGROUNDSmith-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 11016653
- BACKGROUNDGhosh 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 14755683
- BACKGROUNDKinoshita 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 16555021
- BACKGROUNDMurphy 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
- BACKGROUNDMilowsky 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 17290063
- BACKGROUNDVallabhajosula 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.