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,
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. — View Citation
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
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-04-02 — View Citation
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: 10.1 — View Citation
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
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. — View Citation
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
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. — View Citation
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
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. — View Citation
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
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
* 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04555642 -
Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
|
||
Recruiting |
NCT05004961 -
The Performance of Multi-tracer Multimodality PET in Lymphoma
|
||
Recruiting |
NCT05188872 -
Application of 68Ga-Pentixafor PET/CT in Primary Aldosteronism and Pre-postoperative of SAAE
|
N/A | |
Recruiting |
NCT04983095 -
Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05610098 -
Gene Expression Profiles in Spinal Tuberculosis.
|
||
Recruiting |
NCT04416165 -
Comparison of FDG and FAPI in Patients With Various Types of Cancer
|
N/A | |
Recruiting |
NCT04750772 -
Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer
|
N/A | |
Recruiting |
NCT04831541 -
68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer
|
Early Phase 1 | |
Recruiting |
NCT06188468 -
ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors
|
N/A | |
Recruiting |
NCT06017973 -
The Role of Imaging in the Diagnosis, Management and Prognosis of Possible Non-convulsive Status Epilepticus
|
N/A | |
Recruiting |
NCT03830242 -
Diagnostic Significance of FDG PET/CT Dynamic Imaging in Detecting Metastatic Lymph Nodes With Papillary Thyroid Cancer.
|
N/A | |
Recruiting |
NCT06387381 -
68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
|
Early Phase 1 | |
Recruiting |
NCT05506566 -
68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04367948 -
Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma
|
N/A | |
Recruiting |
NCT05757804 -
Study of 18F-0502B PET Imaging Targeting α-synuclein in the Diagnosis of α-synuclein-related Diseases
|
||
Completed |
NCT05392205 -
Comaprison of 68Ga-FAP-2286 and 18F-FDG PET/CT in Patients With Various Types of Cancer
|
N/A | |
Completed |
NCT03741231 -
18FDG-PET in Patients With Melanoma or NSCLC Treated With Immunotherapy
|
||
Completed |
NCT01035164 -
Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03107663 -
⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma
|
Phase 1 | |
Recruiting |
NCT03636607 -
Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions of Primary Hepatocellular Carcinoma
|
N/A |