Clinical Application of 99mTc-FDPH46 SPECT/CT Imaging in Malignant Solid Tumor: a Prospective Exploratory Study
NCT ID: NCT06753513
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
20 participants
OBSERVATIONAL
2024-12-28
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* What is the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors, compared to the pathological gold standard?
* What is the biodistribution, tumor uptake and safety of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors?
Participant Will:
• Patients with clinically suspected or diagnosed malignant solid tumors who are willing to undergo 99mTc-FDPH46 SPECT/CT examination and sign an informed consent form.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patient Self-Control
Patient Self-Control
99mTc-FDPH46 SPECT/CT Imaging
99mTc-FDPH46 SPECT/CT Imaging
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
99mTc-FDPH46 SPECT/CT Imaging
99mTc-FDPH46 SPECT/CT Imaging
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Ages between 18 to 80 years old.
3. Stable vital signs, ECOG score of 0-2, capable of tolerating and cooperating with the 99mTc-FDPH46 SPECT/CT examination.
4. Subjects who are willing to undergo the 99mTc-FDPH46 SPECT/CT examination and have signed the informed consent form.
Exclusion Criteria
2. Contraindications for SPECT imaging (including pregnant women, nursing women, women of childbearing age with recent plans to conceive, etc.).
3. Unstable vital signs, ECOG score \>2, unable to tolerate or cooperate with the 99mTc-FDPH46 SPECT/CT examination process.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
First Affiliated Hospital of Zhejiang University
OTHER
Zhejiang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhang jun
Deputy Chief Physician
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province, China.
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zhang Jun
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Ruan Q, Feng J, Jiang Y, Zhang X, Duan X, Wang Q, Yin G, Xiao D, Zhang J. Preparation and Bioevaluation of 99mTc-Labeled FAP Inhibitors as Tumor Radiotracers to Target the Fibroblast Activation Protein. Mol Pharm. 2022 Jan 3;19(1):160-171. doi: 10.1021/acs.molpharmaceut.1c00712. Epub 2021 Dec 14.
Ruan Q, Zhou C, Wang Q, Kang F, Jiang Y, Li G, Feng J, Zong S, Zhang J, Wang J. A Simple Kit Formulation for Preparation and Exploratory Human Studies of a Novel 99mTc-Labeled Fibroblast Activation Protein Inhibitor Tracer for Imaging of the Fibroblast Activation Protein in Cancers. Mol Pharm. 2023 Jun 5;20(6):2942-2950. doi: 10.1021/acs.molpharmaceut.2c01094. Epub 2023 Apr 21.
Ruan Q, Wang Q, Jiang Y, Feng J, Yin G, Zhang J. Synthesis and Evaluation of 99mTc-Labeled FAP Inhibitors with Different Linkers for Imaging of Fibroblast Activation Proteins in Tumors. J Med Chem. 2023 Apr 13;66(7):4952-4960. doi: 10.1021/acs.jmedchem.2c02062. Epub 2023 Mar 27.
Ruan Q, Ding D, Diao L, Feng J, Yin G, Jiang Y, Wang Q, Han P, Jiang J, Zhang J. Synthesis and Preclinical Evaluation of Novel 99mTc-Labeled FAPI-46 Derivatives with Significant Tumor Uptake and Improved Tumor-to-Nontarget Ratios. J Med Chem. 2024 Feb 22;67(4):3190-3202. doi: 10.1021/acs.jmedchem.4c00031. Epub 2024 Feb 6.
Lindner T, Altmann A, Kramer S, Kleist C, Loktev A, Kratochwil C, Giesel F, Mier W, Marme F, Debus J, Haberkorn U. Design and Development of 99mTc-Labeled FAPI Tracers for SPECT Imaging and 188Re Therapy. J Nucl Med. 2020 Oct;61(10):1507-1513. doi: 10.2967/jnumed.119.239731. Epub 2020 Mar 13.
Liu Y, Zhang Q, Zhang Y, Wang J, Wu Y, Yang G, Shi J, Wang F, Xu Z, Jing H. 99mTc-Labeled FAPI SPECT Imaging in Idiopathic Pulmonary Fibrosis: Preliminary Results. Pharmaceuticals (Basel). 2023 Oct 9;16(10):1434. doi: 10.3390/ph16101434.
Luo X, Zhang Z, Cheng C, Wang T, Fang D, Zuo C, Yuan G, Li R, Li X. SPECT Imaging with Tc-99m-Labeled HYNIC-FAPI-04 to Extend the Differential Time Window in Evaluating Tumor Fibrosis. Pharmaceuticals (Basel). 2023 Mar 10;16(3):423. doi: 10.3390/ph16030423.
Jiang Y, Tian Y, Feng B, Zhao T, Du L, Yu X, Zhao Q. A novel molecular imaging probe [99mTc]Tc-HYNIC-FAPI targeting cancer-associated fibroblasts. Sci Rep. 2023 Mar 6;13(1):3700. doi: 10.1038/s41598-023-30806-6.
Ma M, Yang G, Zhao M, Liu Y, Ge X, Jia B, Gao S. Synthesis and Preliminary Study of 99mTc-Labeled HYNIC-FAPi for Imaging of Fibroblast Activation Proteins in Tumors. Mol Pharm. 2024 Feb 5;21(2):735-744. doi: 10.1021/acs.molpharmaceut.3c00886. Epub 2024 Jan 9.
Jia X, Li X, Jia B, Yang Y, Wang Y, Liu Y, Ji T, Xie X, Yao Y, Qiu G, Deng H, Zhu Z, Chen S, Yang A, Gao R. The role of [99mTc]Tc-HFAPi SPECT/CT in patients with malignancies of digestive system: first clinical experience. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1228-1239. doi: 10.1007/s00259-022-06068-1. Epub 2022 Dec 7.
Trujillo-Benitez D, Luna-Gutierrez M, Ferro-Flores G, Ocampo-Garcia B, Santos-Cuevas C, Bravo-Villegas G, Morales-Avila E, Cruz-Nova P, Diaz-Nieto L, Garcia-Quiroz J, Azorin-Vega E, Rosato A, Melendez-Alafort L. Design, Synthesis and Preclinical Assessment of 99mTc-iFAP for In Vivo Fibroblast Activation Protein (FAP) Imaging. Molecules. 2022 Jan 1;27(1):264. doi: 10.3390/molecules27010264.
Boschi A, Urso L, Uccelli L, Martini P, Filippi L. 99mTc-labeled FAPI compounds for cancer and inflammation: from radiochemistry to the first clinical applications. EJNMMI Radiopharm Chem. 2024 May 2;9(1):36. doi: 10.1186/s41181-024-00264-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIT20240134C-R1
Identifier Type: -
Identifier Source: org_study_id