Comparative Study of 99mTc-FAPI SPECT/CT and 68Ga-FAPI PE... | NCT05444686

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

NCT05444686

Sponsor

Xijing Hospital

Status

Unknown status

Last Update Posted

Jul 6, 2022Actual

Enrollment

45Estimated

Phase

Not Applicable

Conditions

99mTc-FAPI-positive Gastrointestinal Tumor

Interventions

99mTc-FAPI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Estimated

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jul 30, 2024Estimated

First Submitted Date

Jun 26, 2022

First Submission Date that Met QC Criteria

Jul 4, 2022

First Posted Date

Jul 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2022

Last Update Posted Date

Jul 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
99mTc-FAPI	Diagnostic Test	inject the tracer to subjects and perform SPECT/CT scans

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SUV of primary and metastases lesions	The standardized uptake values (SUV) in deferent organs and lesions	2 hours after injection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with gastrointestinal tumors: diagnosed by pathological needle biopsy

Exclusion Criteria:

refuse or cannot endure surgery pregnant women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jing Wang, M.D, Ph.D	Contact	86-29-84775449		wangjing@fmmu.edu.cn

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39298637	Derived	Zhou C, Li G, Quan Z, Deng Z, Li G, Zhang M, Kang F, Yang W, Wang J. Prospective Study Comparing [99mTc]Tc-DP-FAPI Quantitative SPECT/CT with [68Ga]Ga-FAPI-04 PET/CT in Patients with Gastrointestinal Tumors. Mol Pharm. 2024 Oct 7;21(10):5297-5304. doi: 10.1021/acs.molpharmaceut.4c00783. Epub 2024 Sep 19.
37083360	Derived