Clinical trial · Interventional
FAP PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application
Fibroblast Activation Protein PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application
- 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)
This clinical trial aims to investigate the value of fibroblast activation protein PET/CT(PET/MR) in the diagnosis, staging, and evaluation of treatment outcomes in malignant tumors. The main question it aims to answer is: Fibroblast Activation Protein PET/CT(PET/MR) whether or in which cases this assay is superior to conventional FDG examination in the diagnosis, staging, and assessment of therapeutic efficacy of malignant tumors, thinking about the reasons behind this. Investigators will screen suitable participants among patients undergoing routine FDG examination. * Participants will sign an informed consent form * Undergo 68Ga-FAPI PET/CT (PET/MR) before surgery or biopsy * Surgical resection or puncture biopsy to obtain pathologic results. Diagnosis of patients with malignant tumors at first diagnosis; clinical staging of tumors; and clinical outcomes of patients with confirmed diagnoses will be assessed after postoperative investigator follow-up. The researchers will compare the FDG exams the participants have had to determine the effectiveness of the fibroblast activating protein test.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumors | Malignant Neoplasm | ALIAS | 0.90 |
| Positron-Emission Tomography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-Fibroblast activation protein inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAPI PET/MRI scan
- description
- The 68Ge/68Ga generator was eluted with 0.1 M HCL solution to achieve 3.0 ml of liquid, which was mixed thoroughly with 20 µg FAPI precursor and 375 µl of 1.25 M sodium acetate. The mixture was placed in a thermostat at 95°C for 10 min. The finished liquid was passed through an activated Sep-pak 18C column and 0.8 ml of 80% ethanol was passed through the Sep-pak 18C column and a 0.2 µm microporous membrane (Pall Co., Ltd.) before the product was collected in a sterile product vial. The equipment scan pf PET/MRI is the SIGNA PET/MR manufactured by GE Healthcare. The scan is performed approximately 40 min after injection of 1.85-3.7 MBq 68Ga-FAPI-04 per kg body weight. Breath-gated corrected step-and-shoot (SS) acquisition mode was used. The scan time was 60 ± 10 min (50-70 min). Dedicated T1- and T2-weighted images and diffusion-weighted images (DWI) of the head and neck, chest, abdomen, and pelvis were acquired.
- interventionNames
- Drug: 68Ga-Fibroblast activation protein inhibitor
Primary outcomes (1)
- measure
- 68Ga-Fibroblast Activation Protein Inhibitor-04 Uptake in Gastrointestinal Cancer: Comparison with 18F-FDG
- timeFrame
- up to 38 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years ≤ 75 years of age; * Patients with clinical suspicion of malignancy; * No invasive tests or treatments recently; * Blood routine: leukocyte \> 4×109/L, neutrophil \> 2×10 9/L, hemoglobin \> 90g/L, platelets \> 100×10 9/L; * Cardiac function: left ventricular ejection fraction \>50%; * Pulmonary function tests: FEV1 ≥1.2L, FEV1% ≥50% and DLCO ≥50%; * Liver function: total bilirubin \<1.5 times upper limit of normal (ULN); AST and ALT \<1.5 times ULN; * Renal function: serum creatinine ≤ 1.5 times ULN, or glomerular filtration rate \> 60 ml/min; * Participants agreed to participate in this clinical trial and signed an informed consent form; * Good compliance and commitment to follow the study procedures and to cooperate in the implementation of the full study; * No birth plans for six months. Exclusion Criteria: * Those with severe psychiatric symptoms, or those who are too confused to cooperate with the examination; * Pregnant and potentially pregnant women, lactating women; * Those with poor compliance.
References
Publications (18)
- RESULTWarburg O, Wind F, Negelein E. THE METABOLISM OF TUMORS IN THE BODY. J Gen Physiol. 1927 Mar 7;8(6):519-30. doi: 10.1085/jgp.8.6.519. No abstract available. PMID 19872213
- RESULTMankoff DA, Eary JF, Link JM, Muzi M, Rajendran JG, Spence AM, Krohn KA. Tumor-specific positron emission tomography imaging in patients: [18F] fluorodeoxyglucose and beyond. Clin Cancer Res. 2007 Jun 15;13(12):3460-9. doi: 10.1158/1078-0432.CCR-07-0074. PMID 17575208
- RESULTChang JM, Lee HJ, Goo JM, Lee HY, Lee JJ, Chung JK, Im JG. False positive and false negative FDG-PET scans in various thoracic diseases. Korean J Radiol. 2006 Jan-Mar;7(1):57-69. doi: 10.3348/kjr.2006.7.1.57. PMID 16549957
- RESULTCheng JD, Valianou M, Canutescu AA, Jaffe EK, Lee HO, Wang H, Lai JH, Bachovchin WW, Weiner LM. Abrogation of fibroblast activation protein enzymatic activity attenuates tumor growth. Mol Cancer Ther. 2005 Mar;4(3):351-60. doi: 10.1158/1535-7163.MCT-04-0269. PMID 15767544
- RESULTPineiro-Sanchez ML, Goldstein LA, Dodt J, Howard L, Yeh Y, Tran H, Argraves WS, Chen WT. Identification of the 170-kDa melanoma membrane-bound gelatinase (seprase) as a serine integral membrane protease. J Biol Chem. 1997 Mar 21;272(12):7595-601. doi: 10.1074/jbc.272.12.7595. PMID 9065413
- RESULTHuber MA, Kraut N, Park JE, Schubert RD, Rettig WJ, Peter RU, Garin-Chesa P. Fibroblast activation protein: differential expression and serine protease activity in reactive stromal fibroblasts of melanocytic skin tumors. J Invest Dermatol. 2003 Feb;120(2):182-8. doi: 10.1046/j.1523-1747.2003.12035.x. PMID 12542520
- RESULTHenry LR, Lee HO, Lee JS, Klein-Szanto A, Watts P, Ross EA, Chen WT, Cheng JD. Clinical implications of fibroblast activation protein in patients with colon cancer. Clin Cancer Res. 2007 Mar 15;13(6):1736-41. doi: 10.1158/1078-0432.CCR-06-1746.