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COMPLETED Phase 1

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

NCT03073395 · View on ClinicalTrials.gov ↗

Study Summary

An phase I study to evaluate the uptake of \[68Ga\]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using \[68Ga\]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of \[68Ga\]P16-093 in prostate cancer patients post primary curative-intent treatment with stable PSA to generate human radiation dosimetry data.

Interventions

  • DRUG [68Ga]P16-093

Study Locations (1)

Pennsylvania

  • University of Pennsylvania — Philadelphia

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2017-07-21
Est. Completion 2023-10-27
Phase Phase 1

Sponsor

Five Eleven Pharma

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03073395

The ClinicalTrials.gov registry entry for NCT03073395 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Five Eleven Pharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention — of which [68Ga]P16-093 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03073395 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03073395 about?

NCT03073395 is a clinical study titled "Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer". An phase I study to evaluate the uptake of \[68Ga\]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using \[68Ga\]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of \[68Ga\]P16-093 in prostate cancer patients pos...

What is the current status of trial NCT03073395?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2017-07-21. Estimated completion is 2023-10-27.

What conditions does trial NCT03073395 study?

This clinical trial studies the following conditions: Prostate Cancer, Renal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03073395?

The interventions under investigation include: [68Ga]P16-093 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03073395?

This trial is sponsored by Five Eleven Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03073395 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial