PET/CT Imaging of GRPR Expression in Various Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Gad Abikhzer
- Phone Number: 514-340-8222
- Email: gad.abikhzer@mcgill.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age 18 years or older Able to understand and provide written informed consent
Diagnosis of a breast cancer or other tumor known or suspected to express GRPR, including:
ER-positive/HER2-negative breast cancer Invasive lobular breast cancer Head and neck squamous cell carcinoma Small-cell lung cancer Ovarian cancer Prostate cancer with biochemical recurrence and a negative PSMA PET/CT Metastatic pancreatic cancer after pancreatic surgery Other tumor with GRPR expression demonstrated on histopathology ECOG performance status 0-3 Under the care of a referring physician Able to tolerate PET/CT imaging, including lying supine for up to 30 minutes with arms above the head and intravenous cannulation
Exclusion Criteria:
Tumor type known in the literature not to express GRPR, unless patient-specific tissue demonstrates GRPR expression Medically unstable condition, including acute cardiac or respiratory distress or hypotension Weight exceeding PET/CT table limit of 200 kg or inability to fit within the 70-cm PET/CT bore Unmanageable claustrophobia Known allergic or hypersensitivity reaction to a prior GRPR-targeting radioligand such as ⁶⁸Ga-RM2 or bombesin analogues Pregnancy Lactation For individuals of childbearing potential, inability to document a negative pregnancy test before tracer administration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: [⁶⁸Ga]-GRPR PET/CT
Participants with breast cancer or other selected GRPR-expressing malignancies will receive a single intravenous administration of approximately 170 MBq ±20% of [⁶⁸Ga]-LY4257529, followed by PET/CT imaging approximately 50-70 minutes after injection.
All participants undergo the same imaging intervention.
|
[⁶⁸Ga]-LY4257529 is an investigational gastrin-releasing peptide receptor (GRPR)-targeted PET radiopharmaceutical.
Participants will receive approximately 170 MBq ±20% (4.6 mCi ±20%) intravenously.
PET/CT imaging will begin approximately 50-70 minutes after administration to evaluate GRPR-targeted tumor uptake and distribution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Per-Patient GRPR PET/CT Detection Rate
Time Frame: After the PET/CT imaging is completed
|
Proportion of participants with at least one GRPR-positive lesion on [⁶⁸Ga]-LY4257529 PET/CT.
Detection rate will be calculated as the number of participants with at least one GRPR-positive lesion divided by the total number of participants in the relevant cancer cohort.
|
After the PET/CT imaging is completed
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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