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[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

ConditionsColorectal CancerEpithelial Ovarian CancerGastric CancerInvasive Lobular Breast CarcinomaPancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBlue Earth Diagnostics

About this trial

This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \[18F\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.

Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.

Eastern Cooperative Oncology Group performance status ≤ 2.

Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).

Disqualifiers

Participants administered any radioisotope within 5 physical half-lives prior to [18F]FPyQCP administration.

Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [18F]FPyQCP administration.

Participants who have recently received any other contrast agent (< 24 hours for intravenous agents and < 5 days for oral agents) before the day of [18F]FPyQCP administration.

Participants with a history of severe claustrophobia or panic attacks when in confined spaces.

Trial design

Design model

Single group

Treatments tested in this trial

  • [18F]FPyQCP

    Drug

    positron emission tomography (PET)/computed tomography (CT) imaging

Treatment groups

71 Participants
are divided into 1 treatment group
Group A: [18F]FPyQCP PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assess radiation dosimetry of [18F]FPyQCP (Cohort A)

Whole body effective dose of a single dose of \[18F\]FPyQCP

Time frame
Up to 360 minutes post injection
2

Assess the diagnostic performance of [18F]FPyQCP in the peritoneum (Cohort B)

Sensitivity and specificity of \[18F\]FPyQCP PET/CT compared to composite standard of truth

Time frame
Until completion of follow-up procedures, up to 42 days post injection

Secondary outcomes

1

Incidence and severity of adverse events using CTCAE version 5.0 (Both Cohorts)

Purpose is to evaluate the safety and tolerability of \[18F\]FPyQCP

Time frame
From screening until safety follow-up (48 hours post injection)
2

Further assess the diagnostic performance of [18F]FPyQCP (Cohort B).

Participant and region level diagnostic performance (where calculable: sensitivity, specificity, positive predictive value, and negative predictive value) with \[18F\]FPyQCP PET/CT compared to composite SOT and participant and region level detection rates.

Time frame
Until completion of follow-up procedures, up to 42 days post injection

Other outcomes

Sponsors and contacts

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

Blue Earth Diagnostics

Lead sponsor

Medpace, Inc.

Collaborator

Source ClinicalTrials.gov
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