Comparative Study of 99mTc-FAPI SPECT/CT and 68Ga-FAPI PET/CT

NCT ID: NCT05444686

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-07-30

Brief Summary

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The purpose of this study is to compare the similarities and differences of 99mTc-FAPI quantitative SPECT/CT and 68Ga-FAPI PET/CT in the diagnosis and staging of gastrointestinal tumors, and clinical diagnosis and economic value of 99mTc-FAPI quantitative SPECT/CT for the gastrointestinal tumors.

Detailed Description

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5 healthy volunteers with whole body 99mTc-FAPI quantitative SPECT/CT scans at 1, 2, 4, 6 and 24 hours after tracer injection (mean dose, 20.0 ± 2.0 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 2, 4, 6 and 24 hours after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.

Forty patients with confirmed or suspected gastrointestinal tumors, whole body 99mTc-FAPI quantitative SPECT/CT scans will be performed on the first day, and whole body 68Ga-FAPI PET/CT scans will be performed on the next day.According to the scans results of the two agents, with SUVmax and SUVmean as the analysis indicators, the number and uptake difference of primary tumor and metastatic lesions will be compared and analyzed.

Conditions

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99mTc-FAPI-positive Gastrointestinal Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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99mTc-FAPI

inject the tracer to subjects and perform SPECT/CT scans

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with gastrointestinal tumors: diagnosed by pathological needle biopsy

Exclusion Criteria

* refuse or cannot endure surgery pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jing Wang, M.D, Ph.D

Role: CONTACT

86-29-84775449

References

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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.

Reference Type DERIVED
PMID: 37083360 (View on PubMed)

Other Identifiers

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KY20222134-C

Identifier Type: -

Identifier Source: org_study_id

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