CancerNCT06284070
Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer
An observational study of Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "EligibilityCriteria" colymn.
Who may be able to join
- Adult patients (≥ 18 years old);
- Suspected or newly diagnosed malignant tumor patients;
- Patients who underwent 18F-FDG and 18F-FAPI PET scans within one week;
- Patients who are able to provide informed consent forms (signed by participants, parents, or legal representatives) and consent forms in accordance with the guidelines of the Clinical Research Ethics Committee.
Who cannot join
- Pregnant women;
- Scanned images with poor image quality due to factors such as body movement;
- Patients with mental illness or other unsuitable conditions for examination, poor compliance, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400010
Xiao Chen, Ph.D, 15922970174, xiaochen229@foxmail.com
Xiao Chen, Ph.D
About this study
Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). In approximately 90% of epithelial derived tumors, FAP is highly overexpressed on the membrane of CAFs. Contrary to CAFs, FAP expression is lower or absent in normal tissues. Therefore, FAP inhibitors (FAPI) targeting FAP can overcome the limitations of 18F-2-fluoro.2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging. But like 18F-FDG, wound healing, fibrosis, and inflammation can also uptake FAPI.. Therefore, a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG, highlighting their advantages and limitations.
Read the detailed description
This study is a prospective, single study and has been approved by the ethics committee. The subjects of this studywere from January 1,2024 to December 31, 2029.The detailed description is as follows:
- Patients: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "Eligibility Criteria" column.
- Clinical data collection: Record the course of disease, laboratory tests (tumor markers, inflammatory markers), PET examinations, and follow-up related imaging (ultrasound, CT, or magnetic resonance imaging（MRI）) information of all patients.
- CT or MRI image analysis: Record the location and number of lesions, measure the long diameter of the primary and metastatic lesions, and the short diameter of lymph nodes on CT or MRI images.
- PET image analysis: Record and evaluate the following indicators: the maximum, mean and peak standardized uptakevalue (SUVmax, SUVmean and SUVpeak), Metabolic lesion volume (MLV), total lesion glycolysis (TLG).
- Statistical analysis: Use descriptive statistical methods to compare the age of patients and the standardized uptake values of FDG and FAPI. Normal distribution data is represented as mean ± standard deviation, while non normal distribution data is represented as median with IQR. Compare the normal distribution data between two groups using paired two sample t-test, and compare the non normal distribution data between two groups using McNemar test. Using a four grid table McNemar χ Compare the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET through 2 tests, calculate and compare the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-FDG and 18F-FAPI PET. Due to the potential impact of tumor type on diagnosis, subgroup analysis was conducted on the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET. Due to the possibility of multiple metastatic lesions in a given participant, the diagnostic results may be correlated within the participant. Therefore, sensitivity analysis of metastatic lesions is also performed based on a generalized linear mixed effects model by combining this correlation between different lesions within the same participant. Double tailed P<0.05 indicates a statistically significant difference.
- Conditions
- Cancer
- Keywords
- FAPI, cancer, FDG, PET
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 18F-FAPI PET were calculated and compared to evaluate the diagnostic efficacy.
Measured: Completed within half year after end of the study
Secondary outcomes (1)
SUV
Standardized uptake value (SUV) of 18F-FDG and 18F-FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: Completed within one week after PET examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Chen, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284070
- Sponsor's protocol ID
- 202433
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hirmas N, Hamacher R, Sraieb M, Kessler L, Pabst KM, Barbato F, Lanzafame H, Kasper S, Nader M, Kesch C, von Tresckow B, Hautzel H, Aigner C, Glas M, Stuschke M, Kummel S, Harter P, Lugnier C, Uhl W, Hadaschik B, Grunwald V, Siveke JT, Herrmann K, Fendler WP. Diagnostic Accuracy of 68Ga-FAPI Versus 18F-FDG PET in Patients with Various Malignancies. J Nucl Med. 2024 Mar 1;65(3):372-378. doi: 10.2967/jnumed.123.266652. Epub 2024 Feb 8.
PubMed 38331453
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer
- ClinicalTrials.gov ID
- NCT06284070
- Acronym / sponsor ID
- 202433
- Conditions
- Cancer
- Keywords
- FAPI, cancer, FDG, PET
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Feb 2024 (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.
Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). In approximately 90% of epithelial derived tumors, FAP is highly overexpressed on the membrane of CAFs. Contrary to CAFs, FAP expression is lower or absent in normal tissues. Therefore, FAP inhibitors (FAPI) targeting FAP can overcome the limitations of 18F-2-fluoro.2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging. But like 18F-FDG, wound healing, fibrosis, and inflammation can also uptake FAPI.. Therefore, a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG, highlighting their advantages and limitations.
Detailed description
This study is a prospective, single study and has been approved by the ethics committee. The subjects of this studywere from January 1,2024 to December 31, 2029.The detailed description is as follows:
- Patients: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "Eligibility Criteria" column.
- Clinical data collection: Record the course of disease, laboratory tests (tumor markers, inflammatory markers), PET examinations, and follow-up related imaging (ultrasound, CT, or magnetic resonance imaging（MRI）) information of all patients.
- CT or MRI image analysis: Record the location and number of lesions, measure the long diameter of the primary and metastatic lesions, and the short diameter of lymph nodes on CT or MRI images.
- PET image analysis: Record and evaluate the following indicators: the maximum, mean and peak standardized uptakevalue (SUVmax, SUVmean and SUVpeak), Metabolic lesion volume (MLV), total lesion glycolysis (TLG).
- Statistical analysis: Use descriptive statistical methods to compare the age of patients and the standardized uptake values of FDG and FAPI. Normal distribution data is represented as mean ± standard deviation, while non normal distribution data is represented as median with IQR. Compare the normal distribution data between two groups using paired two sample t-test, and compare the non normal distribution data between two groups using McNemar test. Using a four grid table McNemar χ Compare the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET through 2 tests, calculate and compare the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-FDG and 18F-FAPI PET. Due to the potential impact of tumor type on diagnosis, subgroup analysis was conducted on the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET. Due to the possibility of multiple metastatic lesions in a given participant, the diagnostic results may be correlated within the participant. Therefore, sensitivity analysis of metastatic lesions is also performed based on a generalized linear mixed effects model by combining this correlation between different lesions within the same participant. Double tailed P<0.05 indicates a statistically significant difference.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects we selected are adults who are not restricted by gender. For details, please refer to the "EligibilityCriteria" colymn.
Key inclusion criteria (4 listed)
- Adult patients (≥ 18 years old);
- Suspected or newly diagnosed malignant tumor patients;
- Patients who underwent 18F-FDG and 18F-FAPI PET scans within one week;
- Patients who are able to provide informed consent forms (signed by participants, parents, or legal representatives) and consent forms in accordance with the guidelines of the Clinical Research Ethics Committee.
Key exclusion criteria (3 listed)
- Pregnant women;
- Scanned images with poor image quality due to factors such as body movement;
- Patients with mental illness or other unsuitable conditions for examination, poor compliance, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic efficacy
Time frame: Completed within half year after end of the study
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 18F-FAPI PET were calculated and compared to evaluate the diagnostic efficacy.
1 secondary outcome
SUV
Time frame: Completed within one week after PET examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Results publication: PubMed 38331453Hirmas N, Hamacher R, Sraieb M, Kessler L, Pabst KM, Barbato F, Lanzafame H, Kasper S, Nader M, Kesch C, von Tresckow B, Hautzel H, Aigner C, Glas M, Stuschke M, Kummel S, Harter P, Lugnier C, Uhl W, Hadaschik B, Grunwald V, Siveke JT, Herrmann K, Fendler WP. Diagnostic Accuracy of 68Ga-FAPI Versus 18F-FDG PET in Patients with Various Malignancies. J Nucl Med. 2024 Mar 1;65(3):372-378. doi: 10.2967/jnumed.123.266652. Epub 2024 Feb 8.
- Diagnostic Accuracy of 68Ga-FAPI Versus 18F-FDG PET in Patients with Various MalignanciesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical 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: looking for participants now, as of the sponsor's last update on 28 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Chen, Ph.D (15922970174, xiaochen229@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy (time frame: Completed within half year after end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284070, which also lists 1 linked publication.
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 28 Feb 2024.