Tumor, SolidNCT05543317
68Ga-FAPI-RGD PET/CT for Dual Integrin αvβ3 and FAP-targeted Imaging in Patients With Various Types of Cancer and Compared With 18F-FDG
A study testing 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT in people with Tumor, Solid and Positron-Emission Tomography, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor, Solid, Positron-Emission Tomography
- What is being tested?
- 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients (aged 18 years or order);
- patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
- patients who had scheduled both 18F-FDG and 68Ga-FAPI-RGD PET/CT scans;
- patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Who cannot join
- patients with non-malignant lesions;
- patients with pregnancy;
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
About this study
As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-RGD positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.
Read the detailed description
As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, Subjects with various types of cancer underwent contemporaneous 68Ga-FAPI-RGD and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-FAPI-RGD were calculated and compared to 18F-FDG PET/CT.
- Conditions
- Tumor, Solid, Positron-Emission Tomography
- Being tested
- 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT
- Keywords
- Tumor, Solid, Positron-Emission Tomography, diagnosis
- Medical subject headings
- Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CTDiagnostic test
Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-RGD, and undergo PET/CT imaging within the specified time. A part of participants will undergo additional 68Ga-FAPI-46 PET/CT for comparison.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI-RGD | Experimental | Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAPI-RGD, and undergo PET/CT imaging within the specified time. Receives: Diagnostic Test: 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy
The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAPI-RGD PET/CT were calculated and compared to evaluate the diagnostic accuracy.
Measured: 30 days
Secondary outcomes (2)
Number of lesions
The numbers of positive primary and metastatic lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation.
Measured: 30 days
SUV
Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAPI-RGD PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Long Sun, PhD, Study chair, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543317
- Sponsor's protocol ID
- 2022KY007
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-FAPI-RGD PET/CT for Dual Integrin αvβ3 and FAP-targeted Imaging in Patients With Various Types of Cancer and Compared With 18F-FDG
- ClinicalTrials.gov ID
- NCT05543317
- Acronym / sponsor ID
- 2022KY007
- Conditions
- Tumor, Solid, Positron-Emission Tomography
- Keywords
- Tumor, Solid, Positron-Emission Tomography, diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-RGD positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.
Detailed description
As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, Subjects with various types of cancer underwent contemporaneous 68Ga-FAPI-RGD and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-FAPI-RGD were calculated and compared to 18F-FDG PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI-RGD | Experimental | Diagnostic Test: 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CTEach subject receives a single intravenous injection of 18F-FDG and 68Ga-FAPI-RGD, and undergo PET/CT imaging within the specified time. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients (aged 18 years or order);
- patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
- patients who had scheduled both 18F-FDG and 68Ga-FAPI-RGD PET/CT scans;
- patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Key exclusion criteria (3 listed)
- patients with non-malignant lesions;
- patients with pregnancy;
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CTEach subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-RGD, and undergo PET/CT imaging within the specified time. A part of participants will undergo additional 68Ga-FAPI-46 PET/CT for comparison. | Diagnostic test | 68Ga-FAPI-RGD |
Primary outcome
Diagnostic efficacy
Time frame: 30 days
The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAPI-RGD PET/CT were calculated and compared to evaluate the diagnostic accuracy.
2 secondary outcomes
Number of lesions
Time frame: 30 days
SUV
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Long Sun, PhD study chair
The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT in people with Tumor, Solid and Positron-Emission Tomography, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.