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68Ga-FAPI PET/CT in Patients With Various Types of Cancer

ConditionsTumorPositron-Emission TomographyMetastasis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Disqualifiers

(i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-DOTA/NOTA-FAPI-04

    Drug

    Each patient receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT scan within specified time.

  • PET/CT scan

    Diagnostic test

    PET/CT scan

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Experimental: 68Ga-DOTA/NOTA-FAPI-04Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Standardized uptake value (SUV)

Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.

Time frame
30 days

Secondary outcomes

1

Diagnostic efficacy

The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.

Time frame
30 days
2

Diagnostic efficacy

The positive predictive value (PPV), negative predictive value (NPV)

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Fujian Medical University

Lead sponsor

Source ClinicalTrials.gov
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