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99mTc-HFAPI SPECT/CT in Pulmonary Fibrosis

Primary Purpose

Pulmonary Fibrosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
99mTc-HFAPI
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Fibrosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: suspected or confirmed pulmonary fibrosis patients; signed written consent. Exclusion Criteria: pregnancy; breastfeeding; known allergy against FAPI any medical conditions that are considered by the investigator to be likely to seriously interfere with study compliance

Sites / Locations

  • Peking union medical college hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients diagnosed with pulmonary fibrosis

Arm Description

Patients of Pulmonary Fibrosis SPECT/CT imaging: The patients were subcutaneously injected with 99mTc-HFAPI and underwent SPECT/CT imaging.

Outcomes

Primary Outcome Measures

Diagnostic accuracy
Qualitative and semi-quantitative analysis (T/N ratio of lesions and adjacent normal tissue, and early and late imaging) of 99mTc-HFAPI SPECT/CT for pulmonary fibrosis

Secondary Outcome Measures

Full Information

First Posted
May 5, 2023
Last Updated
May 5, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05859763
Brief Title
99mTc-HFAPI SPECT/CT in Pulmonary Fibrosis
Official Title
99mTc-Labeled FAPI SPECT Imaging in Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This prospective study will investigate the potential usefulness of 99mTc labeled FAPI SPECT/CT in the diagnosis, treatment response assessment, and follow-up of pulmonary fibrosis.
Detailed Description
Idiopathic pulmonary fibrosis refers to a specific form of chronic fibrous interstitial pneumonia that occurs spontaneously, limited to the lung, and shows features of usual interstitial pneumonia on high resolution computed tomography and histological examination. Radionuclide labeled FAPI has been developed as a new tracer for tumor and inflammatory lesions imaging. Recent studies have shown that FAPI PET/CT imaging is a promising new imaging method for pulmonary fibrosis. HFAPI is obtained by conjugating 99mTc-chelator moiety (6-hydrazinonicotinamide, HYNIC) with FAP targeting moiety. The aim of this study is to investigate the location and extent of 99mTc labeled FAPI tracer (99mTc-HFAPI) in normal and fibrotic lung tissue of patients with pulmonary fibrosis, and to explore the clinical significance of 99mTc-HFAPI SPECT/CT in the diagnosis, treatment response evaluation and follow-up of pulmonary fibrosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients diagnosed with pulmonary fibrosis
Arm Type
Experimental
Arm Description
Patients of Pulmonary Fibrosis SPECT/CT imaging: The patients were subcutaneously injected with 99mTc-HFAPI and underwent SPECT/CT imaging.
Intervention Type
Drug
Intervention Name(s)
99mTc-HFAPI
Intervention Description
Each patient receive a intravenous injection of 99mTc-HFAPI, and undergo SPECT/CT scan within specified time.
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
Qualitative and semi-quantitative analysis (T/N ratio of lesions and adjacent normal tissue, and early and late imaging) of 99mTc-HFAPI SPECT/CT for pulmonary fibrosis
Time Frame
through study completion, an average of 1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: suspected or confirmed pulmonary fibrosis patients; signed written consent. Exclusion Criteria: pregnancy; breastfeeding; known allergy against FAPI any medical conditions that are considered by the investigator to be likely to seriously interfere with study compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Liu, MD
Phone
18511071577
Email
liuyu@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongli Jing, MD
Facility Information:
Facility Name
Peking union medical college hospital
City
Beijing
State/Province
Dongcheng
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Liu, MD
Phone
18511071577
Email
liuyu@pumch.cn

12. IPD Sharing Statement

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99mTc-HFAPI SPECT/CT in Pulmonary Fibrosis

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