Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-20

Study Completion Date

2022-12-31

Brief Summary

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A phase1 study to demonstrate \[68Ga\]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.

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Detailed Description

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Conditions

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Prostate Cancer Bone Metastases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dynamic imaging group

Dynamic imaging of suspected bone metastases with the investigation drug \[68Ga\]P15-041

Group Type EXPERIMENTAL

[68Ga]P15-041

Intervention Type DRUG

Imaging by Positron Emission Tomography after injection of \[68Ga\]P15-041

Whole body dosimetry group

Determination of human dosimetry of the investigation drug \[68Ga\]P15-041

Group Type EXPERIMENTAL

[68Ga]P15-041

Intervention Type DRUG

Imaging by Positron Emission Tomography after injection of \[68Ga\]P15-041

Interventions

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[68Ga]P15-041

Imaging by Positron Emission Tomography after injection of \[68Ga\]P15-041

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical \[99mTc\]MDP scan

Exclusion Criteria

* Estimated creatinine clearance (GFR) \< 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No