TumorEarly Phase 1NCT06455761
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
A Early Phase 1 study testing 68Ga-DOTA-NI-FAPI04 and 68Ga-FAPI/18F-FDG in people with Tumor, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tumor
- What is being tested?
- 68Ga-DOTA-NI-FAPI04 and 68Ga-FAPI/18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2025
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Various solid tumors with available histopathological findings; Signed informed consent.
Who cannot join
- pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Weibing Miao, MD, +86-0591-87981618, miaoweibing@126.com
Guochang Wang, MD, +86-0591-87981619, guochang1007@163.com
About this study
As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
Read the detailed description
Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, showing high efficacy in tumor staging and restaging. As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
- Conditions
- Tumor
- Being tested
- 68Ga-DOTA-NI-FAPI04, 68Ga-FAPI/18F-FDG
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA-NI-FAPI04Drug
Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT.
68Ga-FAPI/18F-FDGDrug
Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18F-FDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTA-NI-FAPI04 PET/ CT | Experimental | Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT. Receives: Drug: 68Ga-DOTA-NI-FAPI04 |
| 68Ga-FAPI/18F-FDG PET/ CT | Experimental | Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18FFDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT. Receives: Drug: 68Ga-FAPI/18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Sensitivity and Specificity of 68Ga-DOTA-NI-FAPI04 in Patients With Various Types of Cancer and comrare it with 68Ga-FAPI/18F-FDG PET/CT.
Measured: through study completion, an average of 3 months
Secondary outcomes (1)
SUV of tumors
Compare the SUV of tumors between 68Ga-DOTA-NI-FAPI04 PET/CT and 68Ga-FAPI/18F-FDG PET/CT.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Weibing, MD, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455761
- Sponsor's protocol ID
- FirstAHFujian-68Ga-FAPI
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 12 Jun 2024
- 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
- ClinicalTrials.gov ID
- NCT06455761
- Acronym / sponsor ID
- FirstAHFujian-68Ga-FAPI
- Conditions
- Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jun 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.
As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
Detailed description
Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, showing high efficacy in tumor staging and restaging. As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTA-NI-FAPI04 PET/ CT | Experimental | Drug: 68Ga-DOTA-NI-FAPI04Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT. |
| 68Ga-FAPI/18F-FDG PET/ CT | Experimental | Drug: 68Ga-FAPI/18F-FDGIntravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18FFDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Various solid tumors with available histopathological findings; Signed informed consent.
Key exclusion criteria (1 listed)
- pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
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-NI-FAPI04Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT. | Drug | 68Ga-DOTA-NI-FAPI04 PET/ CT |
| 68Ga-FAPI/18F-FDGIntravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18F-FDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT. | Drug | 68Ga-FAPI/18F-FDG PET/ CT |
Primary outcome
Diagnostic value
Time frame: through study completion, an average of 3 months
Sensitivity and Specificity of 68Ga-DOTA-NI-FAPI04 in Patients With Various Types of Cancer and comrare it with 68Ga-FAPI/18F-FDG PET/CT.
1 secondary outcome
SUV of tumors
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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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.
Weibing Weibing, MD principal investigator
First Affiliated Hospital of Fujian Medical University
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-NI-FAPI04 and 68Ga-FAPI/18F-FDG in people with Tumor, 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: status not confirmed, as of the sponsor's last update on 12 Jun 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.
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?
Results are not available in the source record.
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?
Diagnostic value (time frame: through study completion, an average of 3 months). 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 12 Jun 2024.