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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

Study Summary

This trial is to see if a new imaging agent can be used to find metastatic prostate or renal cancer. The agent will be given to patients who have had primary treatment for their cancer to see if it can help show if the cancer has come back.

Eligible Conditions

Kidney Cancer
Prostate 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Five Eleven Pharma, Inc.Lead Sponsor

5 Previous Clinical Trials

380 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap for patient recruitment in this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that, since its initial posting on July 21st 2017, this clinical trial is actively seeking out 30 patients from a single medical site. It was last updated in April of 2022."

Answered by AI

What potential risks accompany the use of [68Ga]P16-093?

"The safety of [68Ga]P16-093 has been rated a 1 due to the limited information that exists on its efficacy and security as this is only in phase one clinical trials."

Answered by AI

Are there any opportunities for participants to join this clinical trial?

"Affirmative. According to the information presented on clinicaltrials.gov, this medical research is currently recruiting participants. It was first advertised on July 21st 2017 and updated for last time April 29th 2022; with a goal of finding 30 patients from only one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer

2017. "Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03073395.

All > Renal Cancer