Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies

September 8, 2023 updated by: Peter MacCallum Cancer Centre, Australia

A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.

The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia
        • Peter MacCallum Cancer Centre

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent obtained prior to any protocol-specific procedures
  • Male and female patients with histologically confirmed squamous cell carcinoma
  • At least one site of active malignancy, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care
  • Age >/= 18 years
  • Life expectancy >/= 3 months
  • ECOG Performance score of 0-2

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F FPM PET/CT scan
  • Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
  • Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D-18F FPM
Radiation: 18F FPM
Experimental: L-18F FPM
Radiation: 18F FPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration
Time Frame: Up to 28 days following 18F FPM administration (+/- 7 days)
Up to 28 days following 18F FPM administration (+/- 7 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.
Time Frame: 10, 30, 60 and 120 minutes post 18F FPM administration
10, 30, 60 and 120 minutes post 18F FPM administration
Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.
Time Frame: 30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
Absorbed organ doses expressed as micro Sv/MBq of administered D-18F FPM and L-18F FPM, and whole body dose expressed as milliSv/200MBq of administered dose
Time Frame: 10, 30, 60 and 120 minutes post 18F FPM administration
10, 30, 60 and 120 minutes post 18F FPM administration

Collaborators and Investigators

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

Sponsor

Peter MacCallum Cancer Centre, Australia

Investigators

  • Principal Investigator: Ben Solomon, 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)

October 1, 2011

Primary Completion (Actual)

November 3, 2017

Study Completion (Actual)

November 3, 2017

Study Registration Dates

First Submitted

December 16, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimated)

December 24, 2012

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/31

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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