18F-FAPI PET/CT ExaminationNCT05752097
[18F]AlF-NOTA-FAPI-04 PET/CT in Inflammation and Fibrosis in Renal Diseases
An observational study of 18F-FAPI PET/CT Examination and Renal Puncture Biopsy, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
The goal of this observational study is to explore the feasibility of using 18F-labeled FAP molecular probe for PET/CT imaging (18F-FAPI PET/CT) to accurately evaluate inflammation and fibrosis in renal diseases. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- 18F-FAPI PET/CT Examination, Renal Puncture Biopsy
- What is being tested?
- [18F]AlF-NOTA-FAPI-04 PET/CT examination and Renal puncture biopsy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Nov 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 10 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with first clinical diagnosis of nephritis or renal fibrosis.
Who may be able to join
- The pitients of nephritis or fibrosis disease
Who cannot join
- Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
- Renal biopsy cannot be performed for severe exclotting disease
- Complicated with chronic liver disease, myocardial infarction, stroke, and malignant tumor
- Unable to cooperate with renal puncture biopsy due to language communication or other problems
- Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
- Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes
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- Alcohol allergy
- Patients with significant decrease in urine volume due to disease
- Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved protocol
- Other circumstances deemed inappropriate by the investigator for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Wei Zhang, doctor
About this study
Official title: Clinical Study of Fibroblast Activating Protein Inhibitor (FAPI) -Mediated 18F Targeted to Evaluate Inflammation and Fibrosis in Renal Diseases
The goal of this observational study is to explore the feasibility of using 18F-labeled FAP molecular probe for PET/CT imaging (18F-FAPI PET/CT) to accurately evaluate inflammation and fibrosis in renal diseases. The main questions it aims to answer are:
- Can 18F-FAPI PET/CT accurately evaluate the inflammation and fibrosis of kidney disease?
- What is the value of 18F-FAPI PET/CT as a non-invasive assessment of inflammation and fibrosis in kidney disease? Participants will receive [18F]AlF-NOTA-FAPI-04 PET/CT and renal aspiration biopsy.
- Conditions
- 18F-FAPI PET/CT Examination, Renal Puncture Biopsy
- Being tested
- [18F]AlF-NOTA-FAPI-04 PET/CT examination, Renal puncture biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]AlF-NOTA-FAPI-04 PET/CT examinationDevice
The intravenous radiotracer dose is 1.85-2.59 MBq/kg, and imaging will be performed 50-60 min after radiotracer injection. All patients are required to urinate as much as possible for imaging preparations, which reduces the influence of the residual radiotracer in the renal pelvis and calyces. Some patients with poor renal function (GFR<60 mL/min, urine volume < 1000 mL/24 h) will be given diuretics (Furosemide, 0.57 mg/kg). The scope of the whole-body inspection is from the base of the skull to the base of the thigh, using five to six beds (3 min/bed). The matrix was 128×128, the PET layer thickness was 3 mm, and all PET images are reconstructed iteratively.
Renal puncture biopsyProcedure or surgery
The patients undergo renal puncture biopsy one day after PET/CT examination. Pathological results of renal biopsy will be collected after surgery, including but not limited to: pathological diagnosis, proportion of glomerulosclerosis, extent of inflammatory cell infiltration, and degree of renal interstitial fibrosis.
| Study group | Role | What they receive |
|---|---|---|
| Renal inflammatory or fibrotic disease | [18F]AIF-NOTA-FAPI-04 (4.81MBq/Kg) will be injected intravenously according to the patient's body weight. PET/CT examination will be performed 50-60 minutes after the injection of radiotracer. The patients will undergo renal puncture biopsy one day after PET/CT examination. Receives: Device: [18F]AlF-NOTA-FAPI-04 PET/CT examination; Procedure: Renal puncture biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value
The extent of renal uptake of FAPI
Measured: 30minutes after PET/CT examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Feb 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 18F-FAPI PET/CT ExaminationStudies 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
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Wang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752097
- Sponsor's protocol ID
- SCPHNM
- Status last verified
- Jan 2024
- First submitted
- 21 Feb 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Y, Yang X, Liu H, Luo W, Liu H, Lv T, Wang J, Qin J, Ou S, Chen Y. Value of [68Ga]Ga-FAPI-04 imaging in the diagnosis of renal fibrosis. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3493-3501. doi: 10.1007/s00259-021-05343-x. Epub 2021 Apr 7.
PubMed 33829416Conen P, Pennetta F, Dendl K, Hertel F, Vogg A, Haberkorn U, Giesel FL, Mottaghy FM. [68 Ga]Ga-FAPI uptake correlates with the state of chronic kidney disease. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3365-3372. doi: 10.1007/s00259-021-05660-1. Epub 2022 Jan 6.
PubMed 34988624
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Fibroblast Activating Protein Inhibitor (FAPI) -Mediated 18F Targeted to Evaluate Inflammation and Fibrosis in Renal Diseases
- ClinicalTrials.gov ID
- NCT05752097
- Acronym / sponsor ID
- SCPHNM
- Conditions
- 18F-FAPI PET/CT Examination, Renal Puncture Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 2 Mar 2023 (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.
The goal of this observational study is to explore the feasibility of using 18F-labeled FAP molecular probe for PET/CT imaging (18F-FAPI PET/CT) to accurately evaluate inflammation and fibrosis in renal diseases. The main questions it aims to answer are:
- Can 18F-FAPI PET/CT accurately evaluate the inflammation and fibrosis of kidney disease?
- What is the value of 18F-FAPI PET/CT as a non-invasive assessment of inflammation and fibrosis in kidney disease? Participants will receive [18F]AlF-NOTA-FAPI-04 PET/CT and renal aspiration biopsy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal inflammatory or fibrotic disease | – | Device: [18F]AlF-NOTA-FAPI-04 PET/CT examination, Procedure: Renal puncture biopsy[18F]AIF-NOTA-FAPI-04 (4.81MBq/Kg) will be injected intravenously according to the patient's body weight. PET/CT examination will be performed 50-60 minutes after the injection of radiotracer. The patients will undergo renal puncture biopsy one day after PET/CT examination. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with first clinical diagnosis of nephritis or renal fibrosis.
Key inclusion criteria (1 listed)
- The pitients of nephritis or fibrosis disease
Key exclusion criteria (10 listed)
- Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
- Renal biopsy cannot be performed for severe exclotting disease
- Complicated with chronic liver disease, myocardial infarction, stroke, and malignant tumor
- Unable to cooperate with renal puncture biopsy due to language communication or other problems
- Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
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]AlF-NOTA-FAPI-04 PET/CT examinationThe intravenous radiotracer dose is 1.85-2.59 MBq/kg, and imaging will be performed 50-60 min after radiotracer injection. All patients are required to urinate as much as possible for imaging preparations, which reduces the influence of the residual radiotracer in the renal pelvis and calyces. Some patients with poor renal function (GFR<60 mL/min, urine volume < 1000 mL/24 h) will be given diuretics (Furosemide, 0.57 mg/kg). The scope of the whole-body inspection is from the base of the skull to the base of the thigh, using five to six beds (3 min/bed). The matrix was 128×128, the PET layer thickness was 3 mm, and all PET images are reconstructed iteratively. | Device | Renal inflammatory or fibrotic disease |
| Renal puncture biopsyThe patients undergo renal puncture biopsy one day after PET/CT examination. Pathological results of renal biopsy will be collected after surgery, including but not limited to: pathological diagnosis, proportion of glomerulosclerosis, extent of inflammatory cell infiltration, and degree of renal interstitial fibrosis. | Procedure or surgery | Renal inflammatory or fibrotic disease |
Primary outcome
Standardized uptake value
Time frame: 30minutes after PET/CT examination
The extent of renal uptake of FAPI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Background: PubMed 33829416Zhou Y, Yang X, Liu H, Luo W, Liu H, Lv T, Wang J, Qin J, Ou S, Chen Y. Value of [68Ga]Ga-FAPI-04 imaging in the diagnosis of renal fibrosis. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3493-3501. doi: 10.1007/s00259-021-05343-x. Epub 2021 Apr 7.
- Background: PubMed 34988624Conen P, Pennetta F, Dendl K, Hertel F, Vogg A, Haberkorn U, Giesel FL, Mottaghy FM. [68 Ga]Ga-FAPI uptake correlates with the state of chronic kidney disease. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3365-3372. doi: 10.1007/s00259-021-05660-1. Epub 2022 Jan 6.
- 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. This study is not recruiting at the moment.
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 18F-FAPI PET/CT Examination and Renal Puncture Biopsy, run by Sichuan Provincial People's Hospital 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 10 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 24 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Wang, Principal Investigator (+8618313820216, 18810566155@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (time frame: 30minutes after PET/CT examination). 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 NCT05752097, which also lists 2 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 24 Jan 2024.