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
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
Both
Solid Tumors, Gliomas-High Grade, Lung Cancer, Head and Neck Cancer, Sarcoma, Renal Cell Carcinoma (RCC), Breast Cancer
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 Center | Princeton, New Jersey 08540 |
