FAP PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application

Summary

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.

Timeline

Start

2022-04-28

Primary completion

2023-11-28

Completion

2025-05-31

Publications

• Results Warburg 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.
• Results 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.
• Results Chang 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.
• Results Cheng 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.
• Results Pineiro-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.
• Results 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):182-8. doi: 10.1046/j.1523-1747.2003.12035.x.
• Results Henry 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.
• Results Shi M, Yu DH, Chen Y, Zhao CY, Zhang J, Liu QH, Ni CR, Zhu MH. Expression of fibroblast activation protein in human pancreatic adenocarcinoma and its clinicopathological significance. World J Gastroenterol. 2012 Feb 28;18(8):840-6. doi: 10.3748/wjg.v18.i8.840.
• Results Goscinski MA, Suo Z, Florenes VA, Vlatkovic L, Nesland JM, Giercksky KE. FAP-alpha and uPA show different expression patterns in premalignant and malignant esophageal lesions. Ultrastruct Pathol. 2008 May-Jun;32(3):89-96. doi: 10.1080/01913120802034934.
• Results Lai D, Ma L, Wang F. Fibroblast activation protein regulates tumor-associated fibroblasts and epithelial ovarian cancer cells. Int J Oncol. 2012 Aug;41(2):541-50. doi: 10.3892/ijo.2012.1475. Epub 2012 May 14.
• Results Rasanen K, Virtanen I, Salmenpera P, Grenman R, Vaheri A. Differences in the nemosis response of normal and cancer-associated fibroblasts from patients with oral squamous cell carcinoma. PLoS One. 2009 Sep 1;4(9):e6879. doi: 10.1371/journal.pone.0006879.
• Results Dohi O, Ohtani H, Hatori M, Sato E, Hosaka M, Nagura H, Itoi E, Kokubun S. Histogenesis-specific expression of fibroblast activation protein and dipeptidylpeptidase-IV in human bone and soft tissue tumours. Histopathology. 2009 Oct;55(4):432-40. doi: 10.1111/j.1365-2559.2009.03399.x.
• Results 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.
• Results 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.
• Results 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 Patients with Various Cancers. J Nucl Med. 2019 Mar;60(3):386-392. doi: 10.2967/jnumed.118.215913. Epub 2018 Aug 2.
• Results 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.
• Results 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: 10.2967/jnumed.118.224469. Epub 2019 Mar 8.
• Miao J, Xu Y, Qiao F, Chen N, Khan MI, Zhao Y, Wang H. Gastrointestinal cancer with indeterminate 18F-FDG PET/CT findings: Diagnostic efficacy analysis of 68Ga-FAPI-04 PET/MRI. Oncol Lett. 2026 May 13;32(1):292. doi: 10.3892/ol.2026.15647. eCollection 2026 Jul.

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