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

Phase 2

Completed

• Conditions: Solid Tumors; High Grade Gliomas; Lung Cancer; Head and Neck Cancer; Sarcoma; Renal Cell Carcinoma; Breast Cancer
• Interventions: Drug: Fluciclatide Injection

• Registration Number: NCT00918281
• Lead Sponsor: GE Healthcare

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 the corresponding PET acquisitions, and tumors demonstrate detectable levels of 18F uptake on PET.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Results First Submitted: 2013-10-23
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-06
• Last Update Submitted: 2014-06-06
• Results First Posted: 2014-06-09
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluciclatide Injection	Fluciclatide Injection	Fluciclatide Injection

Primary Outcome Measures

Name	Time	Method
Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.	Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.	Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.

Secondary Outcome Measures

Name	Time	Method
The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.	Up to 8 weeks post contrast administration.	Safety was monitored throughout the duration of the subject's participation.

Trial Locations

Locations (1)

101 Carnegie Center; 🇺🇸 Princeton, New Jersey, United States