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


Phase 2
18 Years
N/A
Not Enrolling
Both
Solid Tumors, Gliomas-High Grade, Lung Cancer, Head and Neck Cancer, Sarcoma, Renal Cell Carcinoma (RCC), Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the test-retest reproducibility of [18F]AH111585 uptake by solid tumors following intravenous administration of AH111585 (18F) Injection via PET imaging.

Outcome Time Frame:

Imaging takes approximately 65 minutes per imaging session

Safety Issue:

No

Principal Investigator

Jeffrey Winick, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

GE Healthcare

Authority:

United States: Food and Drug Administration

Study ID:

GE-135-004

NCT ID:

NCT00918281

Start Date:

June 2009

Completion Date:

October 2011

Related Keywords:

  • Solid Tumors
  • Gliomas-High Grade
  • Lung Cancer
  • Head and Neck Cancer
  • Sarcoma
  • Renal Cell Carcinoma (RCC)
  • Breast Cancer
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Glioma
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Neoplasms
  • Sarcoma

Name

Location

101 Carnegie CenterPrinceton, New Jersey  08540