Clinical Application of 99mTc-FDPH46 SPECT/CT Imaging in Malignant Solid Tumor: a Prospective Exploratory Study

NCT06753513 | Not Yet Recruiting DMC

• 1 other identifier: IIT20240134C-R1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study aims to preliminarily evaluate the diagnostic efficacy of 99mTc-FDPH46 SPECT/CT in malignant solid tumors (compared to the pathological gold standard). The main questions it aims to answer are:

• 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.

Conditions

Malignant Tumors; Solid Tumor Malignancy

Keywords

99mTc; FDPH46; SPECT; Malignant Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Compared with the pathological gold standard, assess the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors.

  Using the pathological gold standard as a reference, the sensitivity, specificity, positive predictive value, and negative predictive value of 99mTc-FDPH46 in patients with malignant solid tumors were evaluated. The consistency between the two diagnostic methods was assessed by Kappa analysis, thereby determining the diagnostic efficacy of 99mTc-FDPH46 in patients with malignant solid tumors.

  2024.12-2026.10

Secondary Outcomes (1)

• Assess the safety, biodistribution, and tumor uptake of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors.

  2024.12-2026.12

Study Arms (1)

Patient Self-Control

Patient Self-Control

Other: 99mTc-FDPH46 SPECT/CT Imaging

Interventions

99mTc-FDPH46 SPECT/CT Imaging OTHER

99mTc-FDPH46 SPECT/CT Imaging

Patient Self-Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are clinically suspected or diagnosed with malignant solid tumors.

You may qualify if:

• Patients who are clinically suspected or diagnosed with malignant solid tumors.
• Ages between 18 to 80 years old.
• Stable vital signs, ECOG score of 0-2, capable of tolerating and cooperating with the 99mTc-FDPH46 SPECT/CT examination.
• Subjects who are willing to undergo the 99mTc-FDPH46 SPECT/CT examination and have signed the informed consent form.

You may not qualify if:

• Those who can not understand, comply with the research protocol or are unable to sign the informed consent form.
• Contraindications for SPECT imaging (including pregnant women, nursing women, women of childbearing age with recent plans to conceive, etc.).
• Unstable vital signs, ECOG score \>2, unable to tolerate or cooperate with the 99mTc-FDPH46 SPECT/CT examination process.

Sponsors & Collaborators

• Zhejiang University: lead
• First Affiliated Hospital of Zhejiang University: collaborator

Study Sites (1)

No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province, China.

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (12)

• 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.

  PMID: 34904839 BACKGROUND

• 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.

  PMID: 37083360 BACKGROUND

• 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.

  PMID: 36972467 BACKGROUND

• 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.

  PMID: 38320123 BACKGROUND

• 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.

  PMID: 32169911 BACKGROUND

• 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.

  PMID: 37895905 BACKGROUND

• 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.

  PMID: 36986521 BACKGROUND

• 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.

  PMID: 36879039 BACKGROUND

• 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.

  PMID: 38193393 BACKGROUND

• 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.

  PMID: 36477400 BACKGROUND

• 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.

  PMID: 35011496 BACKGROUND

• 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.

  PMID: 38695960 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Zhang Jun

CONTACT

+（86）15088608182; 1505156@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 31, 2024
• Study Start: December 28, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

CN (1)