Clinical trial · Interventional
Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma
NCT04367948CI-TRIAL-00044896unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Positron-Emission Tomography | — | UNRESOLVED | — |
| Tumor, Solid | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG and 18F-NOTA-FAPI04 PET/CT | Diagnostic Test | — | UNRESOLVED |
| 18F-FDG and 68Ga-NOTA-FAPI04 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 68Ga-NOTA-FAPI04
- description
- Each subject receive a single intravenous injection of 18F-FDG and 68Ga-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
- interventionNames
- Diagnostic Test: 18F-FDG and 68Ga-NOTA-FAPI04 PET/CT
- type
- EXPERIMENTAL
- label
- 18F-NOTA-FAPI04
- description
- Each subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
- interventionNames
- Diagnostic Test: 18F-FDG and 18F-NOTA-FAPI04 PET/CT
Primary outcomes (1)
- measure
- SUV
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (2)
- DERIVEDChen 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 37385675
- DERIVEDWang 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 32632460