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

Early Phase 1

Terminated

• Conditions: Squamous Cell Carcinoma
• Interventions: Radiation: 18F FPM

• Registration Number: NCT01755650
• Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-12-16
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-24
• Primary Completion: 2017-11-03
• Study Completion: 2017-11-03
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-18F FPM	18F FPM	-
L-18F FPM	18F FPM	-

Primary Outcome Measures

Name	Time	Method
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	Up to 28 days following 18F FPM administration (+/- 7 days)

Secondary Outcome Measures

Name	Time	Method
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	10, 30, 60 and 120 minutes post 18F FPM administration
Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.	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.	30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration

Trial Locations

Locations (1)

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Victoria, Australia