Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions (SPECIFIC)

March 14, 2024 updated by: Peter MacCallum Cancer Centre, Australia
This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This open label, single centre, proof of concept pilot imaging trial will evaluate technique for the diagnosis of invasive Aspergillus infection. It aims to demonstrate uptake of the gallium-siderophore tracer at sites of known proven/probable invasive aspergillus app infection. It will also assess the safety and tolerability of this technique.

10 patients within 2 weeks of proven or probable invasive fungal infection (IFI) diagnosis will be recruited to this study over a period of 12-24 months.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients aged 18 years or older at written informed consent who have proven or probable invasive fungal infection (IFI) diagnosis with imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with lesions at least 8mm in diameter. They are also willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up.

Description

Inclusion Criteria:

  1. Patient has provided written informed consent
  2. Aged 18 years or older at written informed consent
  3. Within 2 weeks of proven or probable invasive fungal infection (IFI) diagnosis as per EORTC criteria
  4. Imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with lesions at least 8mm in diameter
  5. Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up

Exclusion Criteria:

  1. Women who are pregnant or lactating.
  2. Iron infusion within one week prior to scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis
Time Frame: At 60 minutes
The maximum standardized uptake value (SUVmax) is widely used for measuring the uptake of FDG by malignant tissue.
At 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiologic bio distribution
Time Frame: Evaluated up to 3 hours following injection of radiotracer
SUVmax in mediastinal blood pool, and any organs with uptake including liver, spleen and marrow
Evaluated up to 3 hours following injection of radiotracer
Safety of 68Ga-TAFC-PET/CT
Time Frame: Evaluated within 24 hours of scan
Adverse events defined by CTCAE v5
Evaluated within 24 hours of scan
Findings compared to CT and/or 18F-FDG PET/CT
Time Frame: At 60 minutes
Descriptive comparison of the siderophore PET to standard of care imaging - looking at areas of uptake and if this corresponds to areas of presumed infection on SOC PET or CT
At 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter MacCallum Cancer Centre, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPECIFIC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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