Status:
COMPLETED
CTT1057, a Small Molecular Inhibitor of PSMA, as a Novel Imaging Agent of Neovascularization in Renal Cell Carcinoma
Lead Sponsor:
Cancer Targeted Technology
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test a novel diagnostic PET imaging agent for safety and biodistribution. The agent binds PSMA and is designed to detect Prostate Specific Membrane Antigen expressing t...
Detailed Description
CTT has developed a PET imaging agent, CTT1057, labeled with 18F, that is based on a small molecule core and targets an extracellular region of PSMA with high affinity. Although comparable to other in...
Eligibility Criteria
Inclusion
- Patients age ≥18 years old
- Histologically confirmed renal cell carcinoma
- Adequate organ function including:
- \- Platelet count of \> 50,000/mm3
- \- Neutrophil count of \> 1000/mm3
- \- Serum Cr \< 1.5 x ULN or estimated GFR \> 60 ml/min based upon Cockroft-Gault equation
- \- Proteinuria \< 1 g/24 hours based upon 24 hour urine collection or spot urine protein/creatinine ratio
- \- AST and ALT \< 2.5 x ULN (\< 5 x ULN in patients with known liver metastases)
- \- Total bilirubin \< 1.5 x ULN (\< 3 x ULN in patients with known/suspected Gilbert's disease)
- ECOG performance status of 0 or 1
- Able to provide written informed consent and willing to comply with protocol requirements
- No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker
- For participants of childbearing potential, not pregnant, and use of effective contraceptive methods during the trial and within 6 months following radiotracer injection
- Cohort A only: Presence of at least three distinct metastatic lesions by standard imaging including whole body bone scan + cross-sectional imaging of the abdomen and pelvis obtained within 12 weeks prior to protocol scan
- Cohort B only: (N = 5 evaluable patients): Planned nephrectomy within 12 weeks following protocol scan
Exclusion
- Patients with or with a history of uncontrolled bleeding diathesis
- Inadequate venous access per assessment of treating health care provider
- Receipt of radioisotope within 5 physical half-lives prior to trial enrollment
- Prior treatment with alpha radiation therapy (Radium Ra 223 chloride; Xofigo™) during the previous 60 days
- Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.
- Prior history of any other malignancy within past three years, except melanomatous skin cancer or carcinoma in situ.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03427476
Start Date
January 1 2018
End Date
August 31 2018
Last Update
April 22 2019
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143