68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients
1 other identifier
interventional
90
1 country
1
Brief Summary
Based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. In this study, a novel dual-target imaging agent 68Ga-RM26-RGD was used for clinical study of tumor PET/CT imaging to further verify its clinical application value.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 breast-cancer
Started Aug 2022
Typical duration for early_phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2022
CompletedFirst Submitted
Initial submission to the registry
September 18, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedJuly 5, 2024
July 1, 2024
3.4 years
September 18, 2022
July 3, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Diagnostic performance1
comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 18F-FDG PET/CT
through study completion, an average of 1 year
Diagnostic performance2
comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RM26 PET/CT
through study completion, an average of 1 year
Diagnostic performance3
comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RGD PET/CT
through study completion, an average of 1 year
Secondary Outcomes (2)
The dosimetry of 68Ga-RM26-RGD
through study completion, an average of 1 year
68Ga-RM26-RGD uptake at different tumors
through study completion, an average of 1 year
Study Arms (3)
68Ga-RM26-RGD and 18F-FDG PET/ CT scan
EXPERIMENTALWithin 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 18F-FDG, respectively.
68Ga-RM26-RGD and 68Ga-RM26 PET/ CT scan
EXPERIMENTALWithin 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 68Ga-RM26, respectively.
68Ga-RM26-RGD and 68Ga-RGD PET/ CT scan
EXPERIMENTALWithin 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 68Ga-RGD, respectively.
Interventions
Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
18F-FDG injection
Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
Eligibility Criteria
You may qualify if:
- patients with confirmed or suspected breast/brain/prostate cancer;
- Ga-RM26-RGD and 18F-FDG(or 68Ga-RM26 or 68Ga-RGD) PET/CT within 2 week;
- signed written consent.
You may not qualify if:
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaohui Zhu, MD,PHD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2022
First Posted
September 22, 2022
Study Start
August 16, 2022
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
July 5, 2024
Record last verified: 2024-07