Clinical trial · Interventional
Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection
A Phase 1 Pilot Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection (PLND)
NCT01572701CI-TRIAL-00019944completedPhase 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 high risk 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. Patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 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
- 20 (±3) mCi of study drug
- interventionNames
- Drug: 99mTc-MIP-1404
Primary outcomes (1)
- measure
- Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404
- timeFrame
- Post-procedure
- description
- 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Secondary outcomes (3)
- measure
- Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose
- timeFrame
- Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection
- description
- Summary tables will present change from pre-dose to post-dose vital signs measurements.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male aged 21 years or older. 2. Ability to provide signed informed consent and willingness to comply with protocol requirements. 3. Past biopsy indicating the presence of adenocarcinoma of the prostate gland. 4. Participant is deemed to be high-risk with potential for pelvic lymph node involvement. The criteria for high-risk are: * Patient has PSA value \>10 and clinical stage T2 or higher, and Gleason score 8, 9 or 10. * Patient has PSA value \>20 and clinical stage T2 or higher, and Gleason score 5. Participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection. 6. Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging prior to surgery. 7. Have had (within previous 2 months) or will undergo bone scan imaging prior to surgery. 8. 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 each injection, if engaged in sexual activity. Exclusion Criteria: 1. Participants for whom participating would significantly delay the scheduled standard of care therapy. 2. Participants administered a radioisotope within 5 physical half lives prior to study enrollment. 3. 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 (13)
- BACKGROUNDJung JA, Coakley FV, Vigneron DB, Swanson MG, Qayyum A, Weinberg V, Jones KD, Carroll PR, Kurhanewicz J. Prostate depiction at endorectal MR spectroscopic imaging: investigation of a standardized evaluation system. Radiology. 2004 Dec;233(3):701-8. doi: 10.1148/radiol.2333030672. PMID 15564406
- BACKGROUNDSwindle P, Eastham JA, Ohori M, Kattan MW, Wheeler T, Maru N, Slawin K, Scardino PT. Do margins matter? The prognostic significance of positive surgical margins in radical prostatectomy specimens. J Urol. 2008 May;179(5 Suppl):S47-51. doi: 10.1016/j.juro.2008.03.137. PMID 18405751
- BACKGROUNDHocht S, Wiegel T, Bottke D, Jentsch H, Sternemann M, Rosenthal P, Hinkelbein W. Computed tomogram prior to prostatectomy. Advantage in defining planning target volumes for postoperative adjuvant radiotherapy in patients with stage C prostate cancer? Strahlenther Onkol. 2002 Mar;178(3):134-8. doi: 10.1007/s00066-002-0896-9. PMID 11962189
- BACKGROUNDKotzerke J, Prang J, Neumaier B, Volkmer B, Guhlmann A, Kleinschmidt K, Hautmann R, Reske SN. Experience with carbon-11 choline positron emission tomography in prostate carcinoma. Eur J Nucl Med. 2000 Sep;27(9):1415-9. doi: 10.1007/s002590000309. PMID 11007527
- 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.