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18F-FDG and 68Ga-FAPI PET/CT in Lung Adenocarcinoma

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Xiamen University

Status

Completed

Conditions

18F-FDG
68Ga-FAPI
PET/CT
Lung Adenocarcinoma

Treatments

Diagnostic Test: 68Ga-FAPI PET/CT scan

Study type

Interventional

Funder types

Other

Identifiers

NCT04588064
KYZ2017-001

Details and patient eligibility

About

To evaluate the potential usefulness of 68Ga-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in lung adenocarcinoma, compared with 18F-FDG PET/CT.

Full description

Participants with lung adenocarcinoma underwent contemporaneous 18F-FDG and 68Ga-FAPI PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy. In addition, the investigators further investigate the performance of 68Ga-FAPI PET/CT for differentiating invasive adenocarcinoma from adenocarcinoma in situ (pre-invasive lesion) or minimally invasive adenocarcinoma in participants with solitary ground-glass opacity nodules.

Enrollment

63 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • (i) aged ≥ 18 years, with newly detected GGNs ≤ 3 cm on LDCT and suspected to be lung cancer, and with no prior treatment;
  • (ii) who accepted undergoing paired 18F-FDG and 68Ga-FAPI-46 PET/CT, with completion within one week of each other;
  • (iii) with planned surgical resection within one month after PET/CT examinations;
  • (iv) with an ability to provide informed consent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion criteria

  • (i) without surgical treatment;
  • (ii) receiving antitumor treatment prior to surgery;
  • (iii) whose postoperative pathology revealed adenocarcinoma beyond stage IA or benign pulmonary lesions;
  • (iv) with concurrent diagnosis of other malignant tumors;
  • (v) with poor image quality or lesions difficult to measure.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

63 participants in 1 patient group

18F-FDG PET/CT scan
Experimental group
Description:
Each subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time.
Treatment:
Diagnostic Test: 68Ga-FAPI PET/CT scan

Trial contacts and locations

1

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Central trial contact

Haojun Chen, PhD; Long Sun, PhD

Data sourced from clinicaltrials.gov

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