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

Breast Cancer Clinical Trial

Official title:

A Test-retest Study to Assess Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of AH111585 (18F) Injection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918281
• Other study ID #: GE-135-004
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2009
• Last updated: June 6, 2014
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: June 2014
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of IndiaUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Renal Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• High Grade Gliomas
• Lung Cancer
• Renal Cell Carcinoma
• Sarcoma
• Solid Tumors

Intervention

Drug:
• Fluciclatide Injection
Fluciclatide Injection (AH111585 (18F) Injection)

Locations

Country	Name	City	State
United States	101 Carnegie Center	Princeton	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
GE Healthcare	BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses), i3 Statprobe, Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.	Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.	No
Secondary	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.	Safety was monitored throughout the duration of the subject's participation.	Up to 8 weeks post contrast administration.	Yes