Positron-Emission Tomography Clinical Trial
Official title:
Fibroblast Activation Protein PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application
NCT number | NCT06270394 |
Other study ID # | MJX |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | April 28, 2022 |
Est. completion date | March 31, 2027 |
Verified date | July 2023 |
Source | The First Affiliated Hospital of Anhui Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 60 |
Est. completion date | March 31, 2027 |
Est. primary completion date | July 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | FirstHAnhuiMU | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Anhui Medical University | National Natural Science Foundation of China |
China,
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Cheng JD, Dunbrack RL Jr, Valianou M, Rogatko A, Alpaugh RK, Weiner LM. Promotion of tumor growth by murine fibroblast activation protein, a serine protease, in an animal model. Cancer Res. 2002 Aug 15;62(16):4767-72. — View Citation
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Giesel FL, Kratochwil C, Lindner T, Marschalek MM, Loktev A, Lehnert W, Debus J, Jager D, Flechsig P, Altmann A, Mier W, Haberkorn U. 68Ga-FAPI PET/CT: Biodistribution and Preliminary Dosimetry Estimate of 2 DOTA-Containing FAP-Targeting Agents in Patient — View Citation
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Hathi DK, Jones EF. 68Ga FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. Radiol Imaging Cancer. 2019 Sep 27;1(1):e194003. doi: 10.1148/rycan.2019194003. eCollection 2019 Sep. No abstract available. — View Citation
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Huber 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) — View Citation
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Liu R, Li H, Liu L, Yu J, Ren X. Fibroblast activation protein: A potential therapeutic target in cancer. Cancer Biol Ther. 2012 Feb 1;13(3):123-9. doi: 10.4161/cbt.13.3.18696. Epub 2012 Feb 1. — View Citation
Loktev A, Lindner T, Burger EM, Altmann A, Giesel F, Kratochwil C, Debus J, Marme F, Jager D, Mier W, Haberkorn U. Development of Fibroblast Activation Protein-Targeted Radiotracers with Improved Tumor Retention. J Nucl Med. 2019 Oct;60(10):1421-1429. doi — View Citation
Mankoff 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. — View Citation
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 68Ga-Fibroblast Activation Protein Inhibitor-04 Uptake in Gastrointestinal Cancer: Comparison with 18F-FDG | 18F-FDG PET/CT and 68Ga-FAPI-04 PET/MR scans were acquired independently for all the participants with pathologically confirmed GI tumors and signs. The ?2 test was used to analyze these two technologies to quantitatively compare the diagnostic effects. The normalized SUVmax values (calculated by dividing a lesion's original SUVmax by the SUVmean of the descending aorta) of selected lesions were measured and analyzed by Student's t-test. A visual assessment system of the regions was prepared. | up to 38 months | |
Secondary | Utility of 68Ga-FAPI-04 PET/MRI combines 18F-FDG PET/CT in the postoperative evaluation of gastrointestinal cancers | 18F-FDG PET/CT and 68Ga-FAPI-04 PET/MR scans were acquired independently for all the participants with pathologically confirmed GI tumors and signs. The ?2 test was used to analyze these two technologies to quantitatively compare the diagnostic effects. The normalized SUVmax values (calculated by dividing a lesion's original SUVmax by the SUVmean of the descending aorta) of selected lesions were measured and analyzed by Student's t-test. A visual assessment system of the regions was prepared. A visual scoring system was established to compare the detectability of primary tumors and metastases in different organs or regions (the peritoneum, abdominal lymph nodes, supradiaphragmatic lymph nodes, liver, ovary, bone, and other tissues). | up to 60 months |
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