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TerminatedNCT01755650Updated Sep 13, 2023

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

An Early Phase 1 interventional study of 18F FPM in Squamous Cell Carcinoma, sponsored by Peter MacCallum Cancer Centre, Australia. Terminated at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Peter MacCallum Cancer Centre, Australia · Early Phase 1, Interventional, and Diagnostic

Why this study was terminated
6 patients were recuited. Due to inability of the tracer to detect regions of interest sufficiently, the trial was closed early.

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Oct 2011, registered Dec 2012).
Phase
Early Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Squamous Cell Carcinoma

Keywords

  • 18F FPM
  • PET/CT
  • microdosing
03

In context

Carcinoma, Squamous Cell

1,772 studies on the registry are indexed under Carcinoma, Squamous Cell; 412 are open to participants now.

This study's enrollment of 6 is below the median of 44 across 1,414 interventional studies indexed under Carcinoma, Squamous Cell.

Browse Carcinoma, Squamous Cell studies →

Lead sponsor

Peter MacCallum Cancer Centre, Australia is the lead sponsor of 80 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    D-18F FPM

    Radiation: 18F FPM

  • Experimental
    L-18F FPM

    Radiation: 18F FPM

Interventions

  • Radiation18F FPM
06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
  • Peter MacCallum Cancer Centre
    East Melbourne, Victoria, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01755650
Lead sponsor
Peter MacCallum Cancer Centre, Australia
Responsible party
Sponsor
First posted
Dec 24, 2012
Start date
Oct 2011
Primary completion
Nov 3, 2017
Completion
Nov 3, 2017
Last update
Sep 13, 2023

Study contacts

Ben Solomon
principal investigator · Peter MacCallum Cancer Centre, Australia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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