TumorEarly Phase 1NCT04499365
68Ga-FAPI PET/CT in Patients With Various Types of Cancer
A Early Phase 1 study testing 68Ga-DOTA/NOTA-FAPI-04 and PET/CT scan in people with Tumor and Positron-Emission Tomography, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tumor, Positron-Emission Tomography, Metastasis
- What is being tested?
- 68Ga-DOTA/NOTA-FAPI-04 and PET/CT scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2020to 30 Dec 2027
- Phase
- Early Phase 1
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) 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
- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Weibing Miao, MD, 86-0591-87981618, miaoweibing@126.com
Shan Zheng, MD, 86-0591-87981619, zhengshan1982@126.com
About this study
Official title: 68Ga-DOTA/NOTA-FAPI-04 PET/CT in Patients With Various Types of Cancer
To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.
Read the detailed description
Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.
- Conditions
- Tumor, Positron-Emission Tomography, Metastasis
- Being tested
- 68Ga-DOTA/NOTA-FAPI-04, PET/CT scan
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA/NOTA-FAPI-04Drug
Each patient receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT scan within specified time.
PET/CT scanDiagnostic test
PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 68Ga-DOTA/NOTA-FAPI-04 | Experimental | Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time. Receives: Drug: 68Ga-DOTA/NOTA-FAPI-04; Diagnostic Test: PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUV)
Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: 30 days
Secondary outcomes (2)
Diagnostic efficacy
The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.
Measured: 30 days
Diagnostic efficacy
The positive predictive value (PPV), negative predictive value (NPV)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start15 Aug 2020
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499365
- Sponsor's protocol ID
- FirstAHFujian3
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng S, Lin J, Zhu Y, Chen Y, Zhang J, Chen X, Miao W. 68Ga-FAPI Versus 18F-FDG PET/CT in Evaluating Newly Diagnosed Breast Cancer Patients: A Head-to-Head Comparative Study. Clin Nucl Med. 2023 Mar 1;48(3):e104-e109. doi: 10.1097/RLU.0000000000004523. Epub 2023 Jan 10.
PubMed 36723892Chen Y, Zheng S, Zhang J, Yao S, Miao W. 68Ga-DOTA-FAPI-04 PET/CT imaging in radioiodine-refractory differentiated thyroid cancer (RR-DTC) patients. Ann Nucl Med. 2022 Jul;36(7):610-622. doi: 10.1007/s12149-022-01742-8. Epub 2022 May 12.
PubMed 35551610Zheng S, Lin R, Chen S, Zheng J, Lin Z, Zhang Y, Xue Q, Chen Y, Zhang J, Lin K, You X, Yao S, Miao W. Characterization of the benign lesions with increased 68Ga-FAPI-04 uptake in PET/CT. Ann Nucl Med. 2021 Dec;35(12):1312-1320. doi: 10.1007/s12149-021-01673-w. Epub 2021 Aug 23.
PubMed 34424505
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-DOTA/NOTA-FAPI-04 PET/CT in Patients With Various Types of Cancer
- ClinicalTrials.gov ID
- NCT04499365
- Acronym / sponsor ID
- FirstAHFujian3
- Conditions
- Tumor, Positron-Emission Tomography, Metastasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 Aug 2020 (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.
To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.
Detailed description
Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: 68Ga-DOTA/NOTA-FAPI-04 | Experimental | Drug: 68Ga-DOTA/NOTA-FAPI-04, Diagnostic Test: PET/CT scanEach subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) 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 (1 listed)
- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) 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 |
|---|---|---|
| 68Ga-DOTA/NOTA-FAPI-04Each patient receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT scan within specified time. | Drug | Experimental: 68Ga-DOTA/NOTA-FAPI-04 |
| PET/CT scanPET/CT scan | Diagnostic test | Experimental: 68Ga-DOTA/NOTA-FAPI-04 |
Primary outcome
Standardized uptake value (SUV)
Time frame: 30 days
Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.
2 secondary outcomes
Diagnostic efficacy
Time frame: 30 days
Diagnostic efficacy
Time frame: 30 days
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 21 Jul 2026.
- Derived from this study: PubMed 36723892Zheng S, Lin J, Zhu Y, Chen Y, Zhang J, Chen X, Miao W. 68Ga-FAPI Versus 18F-FDG PET/CT in Evaluating Newly Diagnosed Breast Cancer Patients: A Head-to-Head Comparative Study. Clin Nucl Med. 2023 Mar 1;48(3):e104-e109. doi: 10.1097/RLU.0000000000004523. Epub 2023 Jan 10.
- Derived from this study: PubMed 35551610Chen Y, Zheng S, Zhang J, Yao S, Miao W. 68Ga-DOTA-FAPI-04 PET/CT imaging in radioiodine-refractory differentiated thyroid cancer (RR-DTC) patients. Ann Nucl Med. 2022 Jul;36(7):610-622. doi: 10.1007/s12149-022-01742-8. Epub 2022 May 12.
- Derived from this study: PubMed 34424505Zheng S, Lin R, Chen S, Zheng J, Lin Z, Zhang Y, Xue Q, Chen Y, Zhang J, Lin K, You X, Yao S, Miao W. Characterization of the benign lesions with increased 68Ga-FAPI-04 uptake in PET/CT. Ann Nucl Med. 2021 Dec;35(12):1312-1320. doi: 10.1007/s12149-021-01673-w. Epub 2021 Aug 23.
- 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?
A Early Phase 1 study testing 68Ga-DOTA/NOTA-FAPI-04 and PET/CT scan in people with Tumor and Positron-Emission Tomography, run by First Affiliated Hospital of Fujian 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 1 inclusion and 1 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 21 Jul 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Weibing Miao, MD (86-0591-87981618, miaoweibing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (SUV) (time frame: 30 days). 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 NCT04499365, which also lists 3 linked publications.
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 21 Jul 2026.