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[68Ga]P16-093 for Kidney Cancer

Phase 1

Waitlist Available

Research Sponsored by Five Eleven Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 hours after injection

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new imaging agent to help doctors see prostate or renal cancer cells in patients. It works by attaching to a protein on the cancer cells, making them visible on scans.

Eligible Conditions

Prostate Cancer
Kidney Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0.5 - 3 hours after injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0.5 - 3 hours after injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0.5 - 3 hours after injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiation dosimetry of [68Ga]P16-093 in patients with a history of prostate cancer

Uptake of [68Ga]P16-093 in metastatic prostate and renal cancer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dynamic groupExperimental Treatment1 Intervention

Dynamic imaging of suspected metastatic lesions with the investigation drug \[68Ga\]P16-093 in patients with a history of histologically confirmed cancer.

Group II: Biodistribution groupExperimental Treatment1 Intervention

Whole body imaging to determine human dosimetry of the investigational drug \[68Ga\]P16-093

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