Clinical Study of Trap-(FAPI)3 PET Imaging in the Diagnosis of Pulmonary Nodules

ConditionLung Nodules
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

The excellent tumor-targeting efficacy of FAP has been confirmed by multiple clinical studies. The results unequivocally establish FAPI as a tumor-targeting ligand with significant potential, demonstrating important application prospects in translational oncology. However, its therapeutic effects remain under investigation. An ideal radiopharmaceutical for cancer treatment should possess outstanding targeting specificity and relatively prolonged tumor retention time. Previous studies have shown that radiolabeled FAPI variants (FAPI-04 and FAPI-46) rapidly and satisfactorily accumulate in tumors, while exhibiting low physiological uptake in normal tissues. However, prior FAP-related tracers demonstrated relatively short retention times in small pulmonary lesions. Our aim is to design a FAPI trimer, Trap-(FAPI)3, to optimize pharmacokinetics and evaluate whether this novel drug offers superior advantages over its monomer analogs in the imaging diagnosis and staging of pulmonary tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Patients aged over 18 years with no gender restriction;

2) Patients with radiographic findings of pulmonary nodules;

3) Patients eligible for Trap-(FAPI)3 PET examination;

4) Written informed consent signed by the subject or their legal guardian.

Disqualifiers

1) Patients who have received antitumor therapy prior to PET/CT scanning;

2) Patients with severe diseases that cannot tolerate PET/CT scanning;

3) Alternative subjects with contraindications to PET/CT scanning;

4) Radiation exposure exceeding 50 mSv dose in the past year;

Trial population

The subjects we selected are adults who are not restricted by gender. Fordetails, please refer to the "EligibilityCriteria" colymn.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: patients with pulmonary nodules

Trial outcomes

Primary outcomes

1

Diagnostic efficacy of Trap-(FAPI)3 probe for pulmonary nodules

sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,

Time frame
through study completion, an average of 1 year
2

Histologic Scores for Fibrotic

Paraffin section specimens were stained by using Masson trichrome for the histologic fibrosis score. Two pathologists graded the histologic slices from the most severe areas for fibrosis by using a semiquantitative scoring system. The fibrosis score was scored between 0 and 3 points as follows: 0: none (No fibrosis), 1: mild (Minimal fibrosis in submucosa or subserosa), 2: moderate (Increased submucosal fibrosis, septa into muscularis propria and/or septa through muscularis propria, increase in subserosal collage), 3: severe (Significant transmural scar, marked subserosal collagen).

Time frame
Completed within one week after surgery
3

Metabolic parameters

Total Lesion Glycolysis (TLG) of bowel lesions are measured on PET.

Time frame
Completed within one week after PET examination

Secondary outcomes

Other outcomes

Sponsors and contacts

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