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

General Electric (GE)

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Sarcoma

Lung Cancer

Renal Cell Carcinoma

Head and Neck Cancer

Solid Tumors

High Grade Gliomas

Treatments

Drug: Fluciclatide Injection

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00918281

GE-135-004

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.