Clinical trial NCT00918281: Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumors
High Grade Gliomas
Lung Cancer
Head and Neck Cancer
Sarcoma
Renal Cell Carcinoma
Breast Cancer
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses)
name: Quintiles, Inc.
name: i3 Statprobe
First posted: 2009-06-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.
Secondary outcomes:
measure: 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.
timeFrame: Up to 8 weeks post contrast administration.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: 101 Carnegie Center
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Jeffrey Winick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: