Comparing 18F-FAPI-04 and 18F-FDG PET/CT in Cancer Detection

NCT06206642 | Completed

• 1 other identifier: XTian
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating fluoro-18-fibroblast activation protein inhibitor-04 positron emission computed tomography's diagnostic efficacy for primary malignancies versus 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose.

Conditions

Malignant Neoplasm

Keywords

18F-FDG; 18F-FAPI; PET/CT

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 18F-FAPI-04 PET/CT

  McNemar test

  1 week

Study Arms (2)

18F-FAPI-04

EXPERIMENTAL

18F-FAPI-04 PET-CT is injected through the patient's elbow vein without special preparation at a dose of 2.96-5.55 megabecquerels (MBq) /kg (0.08-0.15 millicurie/kg).

Diagnostic Test: PET/CT

18F-FDG

EXPERIMENTAL

Before the 18F-FDG PET/CT examination, all patients should fast for at least 4-6 hours, and the fasting blood glucose should be controlled to less than 9.0mmol/L to avoid difficulties in image analysis due to poor blood glucose in patients. 18F-FDG is administered via the patient's elbow vein at a dose of 2.96-5.55 megabecquerels (MBq) /kg (0.08-0.15 millicurie/kg).

Diagnostic Test: PET/CT

Interventions

PET/CT DIAGNOSTIC_TEST

Low-dose CT images were first collected during scanning. The tube voltage was 120kilovolt, the tube current was 50-220Milliampere and the layer thickness was 3.75mm.

18F-FAPI-04; 18F-FDG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years old); PET/CT examination is required after evaluation by oncologist. Healthy persons who volunteer for PET/CT scans; Can cooperate to complete the inspection process; I or family members, legal representatives agree to participate in the study and can sign the informed consent in person.

You may not qualify if:

• The patient has a serious underlying disease or mental illness and is unable to cooperate with the PET/CT examination; Have received systematic chemotherapy; Previous history of primary tumor; Pregnancy; I or family members, legal representatives are unable or unwilling to provide written informed consent.

Sponsors & Collaborators

• Lanzhou University Second Hospital: lead

Study Sites (1)

The Second Hospital of Lanzhou University

Lanzhou, Gansu, 730030, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Liu Jiangyan

  Lanzhou University Second Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: April 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

CN (1)