TerminatedEarly Phase 1

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

Stopped: 6 patients were recuited. Due to inability of the tracer to detect regions of interest sufficiently, the trial was closed early.

Australia6 participantsStarted 2011-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Up to 28 days following 18F FPM administration (+/- 7 days)

Trial details

NCT IDNCT01755650

SponsorPeter MacCallum Cancer Centre, Australia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-03

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