Tumor, SolidNCT04367948
Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma
A study testing 18F-FDG and 68Ga-NOTA-FAPI04 PET/CT and 18F-FDG and 18F-NOTA-FAPI04 PET/CT in people with Tumor, Solid and Positron-Emission Tomography, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To evaluate the normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tumor, Solid, Positron-Emission Tomography, Lymphoma
- What is being tested?
- 18F-FDG and 68Ga-NOTA-FAPI04 PET/CT and 18F-FDG and 18F-NOTA-FAPI04 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to Dec 2022
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG score 0 or 1
- subjects with lymphoma or suspected tumor subjects who have recently (within 2 months) planned to receive pathological biopsy or tumor surgery
- expected survival ≥12 weeks
- blood routine, liver and kidney function meet the following criteria: blood routine: WBC≥4.0×109L or neutrophils ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L;PT and APTT ULN 1.5 or less;Liver and kidney function: t-bil ≤1.5×ULT(upper limit of normal value), ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis);BUN 1.5 x or less ULT, SCr 1.5 x or less ULT
- at least one measurable target lesion according to RECIST1.1
- women must use effective contraception during the study period and for 6 months after the end of the study (effective contraception means sterilization, hormone devices, condoms, contraceptives/pills, abstinence or vasectomy by a partner, etc.);Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period
- able to understand and sign the informed consent voluntarily, with good compliance.
Who cannot join
- severe abnormalities of liver and kidney function;
- women preparing for pregnancy, pregnancy and lactation;
- cannot lie supine for half an hour;
- refuse to join the clinical researcher;
- suffering from claustrophobia or other mental illness;
- conditions that other researchers considered inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Xuejuan Wang, MD, 86 10-88196363, xuejuan_wang@hotmail.com
About this study
To evaluate the normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma
Read the detailed description
Subjects first undergo an 18F-FDG test, followed by 68Ga-NOTA-FAPI04 or 18F-NOTA-FAPI04 test in groups.Investigate the standardized uptake value(SUV) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion, the ratio of the standardized uptake value(SUVR) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion within each time window to that of the normal corresponding tissue.
- Conditions
- Tumor, Solid, Positron-Emission Tomography, Lymphoma
- Being tested
- 18F-FDG and 68Ga-NOTA-FAPI04 PET/CT, 18F-FDG and 18F-NOTA-FAPI04 PET/CT
- Keywords
- Lymphoma, Positron-Emission Tomography, FAPI
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG and 68Ga-NOTA-FAPI04 PET/CTDiagnostic test
Each subject receive a single intravenous injection of 18F-FDG and 68Ga-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
18F-FDG and 18F-NOTA-FAPI04 PET/CTDiagnostic test
Each subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NOTA-FAPI04 | Experimental | Each subject receive a single intravenous injection of 18F-FDG and 68Ga-NOTA-FAPI04, and undergo PET/CT imaging within the specified time Receives: Diagnostic Test: 18F-FDG and 68Ga-NOTA-FAPI04 PET/CT |
| 18F-NOTA-FAPI04 | Experimental | Each subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time Receives: Diagnostic Test: 18F-FDG and 18F-NOTA-FAPI04 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV
Standardized uptake value of 68Ga/ 18f-nota-fapi04 for target lesion of subject or suspected tumor in each time point window (SUV)
Measured: 60 days
Secondary outcomes (1)
SUVR
the ratio of the standardized uptake value(SUVR) of 68Ga/ 18f-nota-fapi04 for the target lesion or suspected tumor lesion within each time window to that of the normal tissue corresponding to the tumor lesion or suspected tumor lesion to the standardized uptake value of 68Ga/ 18f-nota-fapi04
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (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 Tumor, SolidStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuejuan Wang,MD, Peking University Cancer Hospital & Institute
- Investigators
- Zhi Yang, PhD, Study director, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367948
- Sponsor's protocol ID
- XW-FAPI-001
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen X, Wang S, Lai Y, Wang G, Wei M, Jin X, Ding J, Zhang Y, Shi Y, Wang F, Zhu H, Yang Z, Wang X. Fibroblast Activation Protein and Glycolysis in Lymphoma Diagnosis: Comparison of 68Ga-FAPI PET/CT and 18F-FDG PET/CT. J Nucl Med. 2023 Sep;64(9):1399-1405. doi: 10.2967/jnumed.123.265530. Epub 2023 Jun 29.
PubMed 37385675Wang G, Jin X, Zhu H, Wang S, Ding J, Zhang Y, Yang Z, Wang X. 68Ga-NOTA-FAPI-04 PET/CT in a patient with primary gastric diffuse large B cell lymphoma: comparisons with [18F] FDG PET/CT. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):647-648. doi: 10.1007/s00259-020-04946-0. Epub 2020 Jul 6. No abstract available.
PubMed 32632460
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma
- ClinicalTrials.gov ID
- NCT04367948
- Acronym / sponsor ID
- XW-FAPI-001
- Conditions
- Tumor, Solid, Positron-Emission Tomography, Lymphoma
- Keywords
- Lymphoma, Positron-Emission Tomography, FAPI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Apr 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 normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma
Detailed description
Subjects first undergo an 18F-FDG test, followed by 68Ga-NOTA-FAPI04 or 18F-NOTA-FAPI04 test in groups.Investigate the standardized uptake value(SUV) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion, the ratio of the standardized uptake value(SUVR) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion within each time window to that of the normal corresponding tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NOTA-FAPI04 | Experimental | Diagnostic Test: 18F-FDG and 68Ga-NOTA-FAPI04 PET/CTEach subject receive a single intravenous injection of 18F-FDG and 68Ga-NOTA-FAPI04, and undergo PET/CT imaging within the specified time |
| 18F-NOTA-FAPI04 | Experimental | Diagnostic Test: 18F-FDG and 18F-NOTA-FAPI04 PET/CTEach subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ECOG score 0 or 1
- subjects with lymphoma or suspected tumor subjects who have recently (within 2 months) planned to receive pathological biopsy or tumor surgery
- expected survival ≥12 weeks
- blood routine, liver and kidney function meet the following criteria: blood routine: WBC≥4.0×109L or neutrophils ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L;PT and APTT ULN 1.5 or less;Liver and kidney function: t-bil ≤1.5×ULT(upper limit of normal value), ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis);BUN 1.5 x or less ULT, SCr 1.5 x or less ULT
- at least one measurable target lesion according to RECIST1.1
Key exclusion criteria (6 listed)
- severe abnormalities of liver and kidney function;
- women preparing for pregnancy, pregnancy and lactation;
- cannot lie supine for half an hour;
- refuse to join the clinical researcher;
- suffering from claustrophobia or other mental illness;
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-FDG and 68Ga-NOTA-FAPI04 PET/CTEach subject receive a single intravenous injection of 18F-FDG and 68Ga-NOTA-FAPI04, and undergo PET/CT imaging within the specified time | Diagnostic test | 68Ga-NOTA-FAPI04 |
| 18F-FDG and 18F-NOTA-FAPI04 PET/CTEach subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time | Diagnostic test | 18F-NOTA-FAPI04 |
Primary outcome
SUV
Time frame: 60 days
Standardized uptake value of 68Ga/ 18f-nota-fapi04 for target lesion of subject or suspected tumor in each time point window (SUV)
1 secondary outcome
SUVR
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Derived from this study: PubMed 37385675Chen X, Wang S, Lai Y, Wang G, Wei M, Jin X, Ding J, Zhang Y, Shi Y, Wang F, Zhu H, Yang Z, Wang X. Fibroblast Activation Protein and Glycolysis in Lymphoma Diagnosis: Comparison of 68Ga-FAPI PET/CT and 18F-FDG PET/CT. J Nucl Med. 2023 Sep;64(9):1399-1405. doi: 10.2967/jnumed.123.265530. Epub 2023 Jun 29.
- Derived from this study: PubMed 32632460Wang G, Jin X, Zhu H, Wang S, Ding J, Zhang Y, Yang Z, Wang X. 68Ga-NOTA-FAPI-04 PET/CT in a patient with primary gastric diffuse large B cell lymphoma: comparisons with [18F] FDG PET/CT. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):647-648. doi: 10.1007/s00259-020-04946-0. Epub 2020 Jul 6. No abstract available.
- 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.
Zhi Yang, PhD study director
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG and 68Ga-NOTA-FAPI04 PET/CT and 18F-FDG and 18F-NOTA-FAPI04 PET/CT in people with Tumor, Solid and Positron-Emission Tomography, run by Peking University Cancer Hospital & Institute 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 7 inclusion and 6 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 29 Apr 2020. 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 Xuejuan Wang, MD (86 010 88196363, xuejuan_wang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV (time frame: 60 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 NCT04367948, 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 29 Apr 2020.