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

Early Phase 1TerminatedNCT01755650

Peter MacCallum Cancer Centre, Australia6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Squamous Cell Carcinoma

Interventions

18F FPMRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

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

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

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

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

Data from ClinicalTrials.gov

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