CancerNCT06684028
PET Image Exploration of Novel Tracer [68Ga]-FAPI-JNU Imaging Studies in Patients with Malignant Tumors
A study testing 68Ga-FAPI-JNU in people with Cancer and Solid Malignancies, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
To investigate the biological distribution of a new tracer 68Ga-FAPI-JNU in the primary, metastatic and normal tissues of patients with malignant tumors, and to evaluate the biological distribution of 68GA-FAPI-JNU with standardized uptake values. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer, Solid Malignancies
- What is being tested?
- 68Ga-FAPI-JNU
- 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
- 12 Jul 2023to 31 Jul 2025
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
- Age 18-85 years old, male or female;
- Clinically diagnosed as malignant tumor, diagnostic criteria refer to biopsy or other imaging such as CT and MRI;
- ECOG score is 0-3 points;
Who cannot join
- Patients with a history or allergic constitution to any component of the developer, including alcohol;
- pregnant or lactating women;
- Patients with mental illness or related history;
- Patients who cannot or cannot undergo a PET/CT scan;
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
Affiated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000
Chunjing Yu, 15312238622, ycjwxd1978@jiangnan.edu.cn
About this study
To investigate the biological distribution of a new tracer 68Ga-FAPI-JNU in the primary, metastatic and normal tissues of patients with malignant tumors, and to evaluate the biological distribution of 68GA-FAPI-JNU with standardized uptake values.
Read the detailed description
PET/CT imaging was performed about 1 hour after the patient was injected with the novel tracer 68Ga-FAPI-JNU. SUVmax and SUVmean values of the area of interest were mapped by two diagnostic physicians with more than 5 years of experience after the imaging was completed.
- Conditions
- Cancer, Solid Malignancies
- Being tested
- 68Ga-FAPI-JNU
- Keywords
- FAP, FAPI, PET, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-JNUDrug
Patients will receive the novel tracer 68Ga-FAPI-JNU dose of approximately 2-5 mCi per person
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI-JNU | Experimental | 68Ga-FAPI-JNU is administered through a superficial vein on the back of the hand. A PET/CT scan was performed approximately 1 hour after injection Receives: Drug: 68Ga-FAPI-JNU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the distribution of 68Ga-FAPI-JNU in tumors, metastases and normal tissues
CT and PET scans were performed on the patients injected with 68Ga-FAPI-JNU. After image reconstruction and PET/CT image fusion, the biological distribution of 68Ga-FAPI-JNU in the primary tumor, metastatic tumor and various tissues and organs of the patients was evaluated by radioactive uptake value (standardized uptake value, SUV)
Measured: 4 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start12 Jul 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjing Yu, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684028
- Sponsor's protocol ID
- LS2024013
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Image Exploration of Novel Tracer [68Ga]-FAPI-JNU Imaging Studies in Patients with Malignant Tumors
- ClinicalTrials.gov ID
- NCT06684028
- Acronym / sponsor ID
- LS2024013
- Conditions
- Cancer, Solid Malignancies
- Keywords
- FAP, FAPI, PET, cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 12 Nov 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.
To investigate the biological distribution of a new tracer 68Ga-FAPI-JNU in the primary, metastatic and normal tissues of patients with malignant tumors, and to evaluate the biological distribution of 68GA-FAPI-JNU with standardized uptake values.
Detailed description
PET/CT imaging was performed about 1 hour after the patient was injected with the novel tracer 68Ga-FAPI-JNU. SUVmax and SUVmean values of the area of interest were mapped by two diagnostic physicians with more than 5 years of experience after the imaging was completed.
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-JNU | Experimental | Drug: 68Ga-FAPI-JNU68Ga-FAPI-JNU is administered through a superficial vein on the back of the hand. A PET/CT scan was performed approximately 1 hour after injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
- Age 18-85 years old, male or female;
- Clinically diagnosed as malignant tumor, diagnostic criteria refer to biopsy or other imaging such as CT and MRI;
- ECOG score is 0-3 points;
Key exclusion criteria (4 listed)
- Patients with a history or allergic constitution to any component of the developer, including alcohol;
- pregnant or lactating women;
- Patients with mental illness or related history;
- Patients who cannot or cannot undergo a PET/CT scan;
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-FAPI-JNUPatients will receive the novel tracer 68Ga-FAPI-JNU dose of approximately 2-5 mCi per person | Drug | 68Ga-FAPI-JNU |
Primary outcome
Evaluation of the distribution of 68Ga-FAPI-JNU in tumors, metastases and normal tissues
Time frame: 4 hour
CT and PET scans were performed on the patients injected with 68Ga-FAPI-JNU. After image reconstruction and PET/CT image fusion, the biological distribution of 68Ga-FAPI-JNU in the primary tumor, metastatic tumor and various tissues and organs of the patients was evaluated by radioactive uptake value (standardized uptake value, SUV)
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 22 Jan 2025.
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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 study testing 68Ga-FAPI-JNU in people with Cancer and Solid Malignancies, run by Affiliated Hospital of Jiangnan 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 4 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 22 Jan 2025. 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 chunjing Yu (15312238622, ycj_wxd1978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the distribution of 68Ga-FAPI-JNU in tumors, metastases and normal tissues (time frame: 4 hour). 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 22 Jan 2025.