- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05543954
68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients
September 13, 2022 updated by: Peking Union Medical College Hospital
A Pilot Study of 68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients
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.
Lung cancer tissues express fibroblast activating protein FAP, and also have high expression of integrin αVβ3 receptor on the surface of blood vessels.
In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Conventional 18F-FDG PET/CT has important diagnostic value in cell metabolism level, early metastasis, judging malignant potential and prognosis of tumors.
It has been routinely used for staging and restaging of most tumors, but there are still some tumors with low uptake of 18F-FDG PET/CT.
Moreover, 18F-FDG cannot distinguish between tumors and inflammatory diseases, such as tuberculosis and granuloma.
Receptor imaging with a single target also has some limitations in clinical application.
For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion.
The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors such as lung cancer.
In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer, compared with conventional 18F-FDG, or single target imaging agent 68Ga-RGD or 68Ga-FAPI PET/CT imaging.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhaohui Zhu, MD,PHD
- Phone Number: 86+13611093752
- Email: 13611093752@163.com
Study Contact Backup
- Name: Rongxi Wang
- Phone Number: 86+19800370331
- Email: pumch_jacobwong@163.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Zhaohui Zhu, MD,PHD
- Phone Number: 86+13611093752
- Email: 13611093752@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with confirmed or suspected lung cancer;
- 68Ga-FAPI-RGD and 18F-FDG(or 68Ga-FAPI or 68Ga-RGD) PET/CT within 2 week;
- signed written consent.
Exclusion Criteria:
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 68Ga-FAPI-RGD and 18F-FDG PET/ CT scan
Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 18F-FDG, respectively.
|
Intravenous injection of 68Ga-FAPI-RGD with a dosage of approximately 1.8-2.2
MBq (0.05-0.06 mCi)/kg.
Other Names:
Intravenous injection of 18F-FDG with a dosage of approximately 3.7-5.55
MBq (0.1-0.15 mCi)/kg.
Other Names:
|
Experimental: 68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan
Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-FAPI, respectively.
|
Intravenous injection of 68Ga-FAPI-RGD with a dosage of approximately 1.8-2.2
MBq (0.05-0.06 mCi)/kg.
Other Names:
Intravenous injection of 68Ga-FAPI with a dosage of approximately 1.8-2.2
MBq (0.05-0.06 mCi)/kg.
Other Names:
|
Experimental: 68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan
Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-RGD, respectively.
|
Intravenous injection of 68Ga-FAPI-RGD with a dosage of approximately 1.8-2.2
MBq (0.05-0.06 mCi)/kg.
Other Names:
Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2
MBq (0.05-0.06 mCi)/kg.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic performance1
Time Frame: through study completion, an average of 1 year
|
comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 18F-FDG PET/CT
|
through study completion, an average of 1 year
|
Diagnostic performance2
Time Frame: through study completion, an average of 1 year
|
comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-FAPI PET/CT
|
through study completion, an average of 1 year
|
Diagnostic performance3
Time Frame: through study completion, an average of 1 year
|
comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-RGD PET/CT
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The dosimetry of 68Ga-FAPI-RGD
Time Frame: through study completion, an average of 1 year
|
Measure the distribution of 68Ga-FAPI-RGD in 6-8 lung cancer patients by 3-hour dynamic PET/CT acquisition by dosimetry software
|
through study completion, an average of 1 year
|
68Ga-FAPI-RGD uptake at different time points
Time Frame: through study completion, an average of 1 year
|
The SUV uptake of tumors and metastases in patients with lung cancer was measured at 1, 2, and 3 hours.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zhaohui Zhu, MD,PHD, Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 3, 2022
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
September 13, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (Actual)
September 16, 2022
Study Record Updates
Last Update Posted (Actual)
September 16, 2022
Last Update Submitted That Met QC Criteria
September 13, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCH-NM-FR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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