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

Five Eleven Pharma

Status and phase: Completed; Early Phase 1

Conditions: Prostate Cancer; Bone Metastases

Treatments: Drug: [68Ga]P15-041

Study type: Interventional

Funder types: Industry

Identifiers

NCT02826382

511-0001-A

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Dynamic imaging group

Experimental group

Description:

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

Treatment:

Drug: [68Ga]P15-041

Whole body dosimetry group

Experimental group

Description:

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

Treatment:

Drug: [68Ga]P15-041