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

Comparative Study of 99mTc-FAPI Quantitative SPECT/CT and 68Ga-FAPI PET/CT in Clinical Diagnosis and Staging of Gastrointestinal Tumors

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05444686
Enrollment
45
Registered
2022-07-06
Start date
2022-07-01
Completion date
2024-07-30
Last updated
2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

99mTc-FAPI-positive Gastrointestinal Tumor

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.

Interventions

DIAGNOSTIC_TEST99mTc-FAPI

inject the tracer to subjects and perform SPECT/CT scans

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* patients with gastrointestinal tumors: diagnosed by pathological needle biopsy

Exclusion criteria

* refuse or cannot endure surgery pregnant women

Design outcomes

Primary

MeasureTime frameDescription
SUV of primary and metastases lesions2 hours after injectionThe standardized uptake values (SUV) in deferent organs and lesions

Contacts

Primary ContactJing Wang, M.D, Ph.D
wangjing@fmmu.edu.cn86-29-84775449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026