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

This study has been completed.
Sponsor:
Collaborators:
BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses)
Quintiles
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00918281
First received: June 9, 2009
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Gliomas-High Grade
Lung Cancer
Head and Neck Cancer
Sarcoma
Renal Cell Carcinoma (RCC)
Breast Cancer
 Drug: AH111585 (18F) Injection
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • To assess the test-retest reproducibility of [18F]AH111585 uptake by solid tumors following intravenous administration of AH111585 (18F) Injection via PET imaging. [ Time Frame: Imaging takes approximately 65 minutes per imaging session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess image quality and lesion detectability of [18F] as function of administered activity, by temporal segmentation, and safety of 2 administrations, each of a maximum of 370 MBq, [18F] injections in subjects with solid primary or metastatic tumors. [ Time Frame: Temporal segmentation is performed off-line using the image data acquired from the primary objective. Safety is monitored throughout the duration of the subject's participation up to 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 (AH111585 (18F) Injection) Drug: AH111585 (18F) Injection
AH111585 (18F) Injection
Other Name: Fluciclotide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918281

Locations
United States, New Jersey
101 Carnegie Center
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses)
Quintiles
i3 Statprobe
Investigators
Principal Investigator: Jeffrey Winick, Ph.D. GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00918281     History of Changes
Other Study ID Numbers: GE-135-004
Study First Received: June 9, 2009
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma, Renal Cell
Glioma
Head and Neck Neoplasms
Lung Neoplasms
Neoplasms
Sarcoma
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on May 16, 2013