Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection

Completed · Phase 2

Conditions studied: Solid Tumors, High Grade Gliomas, Lung Cancer, Head and Neck Cancer, Sarcoma, Renal Cell Carcinoma, Breast Cancer

In brief

Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels of 18F uptake on PET.

Key facts

Study ID

NCT00918281

Run by

GE Healthcare

People needed

70

Starts

2009-06-01

Expected to finish

2011-10-01

Last updated by the study team

2014-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject has been diagnosed with at least one solid primary or metastatic tumor greater than 2.0 cm in diameter, including but not limited to NSCLC, RCC, GBM, melanoma, sarcoma, breast and H\&N cancers.
• The subject has received clinical routine imaging diagnostic work-up within 8 weeks prior to the first [18F]AH111585 PET scan.
• The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care.

You may not qualify if…

• The subject has known hyper- or hypo-coagulation syndromes.
• The subject has received chemotherapy within 3 weeks, or received radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to the first [18F]AH111585 PET scan.
• The subject is scheduled to undergo chemotherapy, radiotherapy, surgery or any other treatment against cancer between the first and second [18F]AH111585 PET scans.
• The subject is scheduled to undergo biopsy for the target tumour between the first and second [18F]AH111585 PET scans.
• The subject has intra-hepatic tumour(s) only.
• For the immuno-histochemistry group, the subject's target tumour has been biopsied less than or equal to 1 week prior to the first [18F]AH111585 PET scan.

Where it is running

• 101 Carnegie Center — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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