Health TrialsbyHealthPanel

68Ga-XACP3 PET/CT in Prostate Cancer

ConditionsProstate CancerPET/CTACP3
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

The objective of the study is to construct a noninvasive approach 68Ga-XACP3 PET/CT to detect tumor lesions in patients with prostate cancer and to compare with 68Ga-PSMA PET/CT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (aged 18 years or older);

Patients with newly diagnosed, highly suspected recurrence or previously treated metastases of prostate cancer (supporting evidence may include MRI, CT, tumor markers, and pathology report);

Patients who had scheduled both standard-of-care imaging (68Ga-PSMA PET/CT) and 68Ga-XACP3 PET/CT scans;

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

The inability or unwillingness of the research participant or legal representative to provide written informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • Diagnostic Test: standard-of-care imaging (68Ga-PSMA PET/CT), 68Ga-XACP3 PET/CT

    Diagnostic test

    Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceutical (68Ga-PSMA) and 68Ga-XACP3, and undergoes PET/CT imaging within the specified time.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: 68Ga-XACP3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic efficacy

Description: The sensitivity, specificity, and accuracy of standard-of-care imaging (68Ga-PSMA PET/CT) and 68Ga-XACP3 PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Time frame
1 years

Secondary outcomes

1

Number of lesions

The numbers of positive primary and metastatic lesions of standard-of-care imaging (68Ga-PSMA PET/CT) and 68Ga-XACP3 PET/CT were recorded by visual interpretation.

Time frame
1 years
2

SUV

Standardized uptake value (SUV) of standard-of-care imaging (68Ga-PSMA PET/CT) and 68Ga-XACP3 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.

Time frame
1 years

Other outcomes

Sponsors and contacts

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

The First Affiliated Hospital of Xiamen University

Lead sponsor

Source ClinicalTrials.gov
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