Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma
1 other identifier
interventional
200
1 country
1
Brief Summary
To evaluate the normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 29, 2020
April 1, 2020
1.6 years
April 26, 2020
April 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SUV
Standardized uptake value of 68Ga/ 18f-nota-fapi04 for target lesion of subject or suspected tumor in each time point window (SUV)
60 days
Secondary Outcomes (1)
SUVR
60 days
Study Arms (2)
68Ga-NOTA-FAPI04
EXPERIMENTALEach 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
EXPERIMENTALEach subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
Interventions
Each subject receive a single intravenous injection of 18F-FDG and 68Ga-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
Each subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Related Publications (2)
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.
PMID: 37385675DERIVEDWang 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.
PMID: 32632460DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhi Yang, PhD
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 26, 2020
First Posted
April 29, 2020
Study Start
May 1, 2020
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
April 29, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share