Status:
COMPLETED
Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses)
Quintiles, Inc.
Conditions:
Solid Tumors
High Grade Gliomas
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00918281
Start Date
June 1 2009
End Date
October 1 2011
Last Update
June 9 2014
Active Locations (1)
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1
101 Carnegie Center
Princeton, New Jersey, United States, 08540