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

Primary Purpose

Solid Tumors, High Grade Gliomas, Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluciclatide Injection
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • 101 Carnegie Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluciclatide Injection

Arm Description

Fluciclatide Injection

Outcomes

Primary Outcome Measures

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.
Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.

Secondary Outcome Measures

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.
Safety was monitored throughout the duration of the subject's participation.

Full Information

First Posted
June 9, 2009
Last Updated
June 6, 2014
Sponsor
GE Healthcare
Collaborators
BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses), Quintiles, Inc., i3 Statprobe
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1. Study Identification

Unique Protocol Identification Number
NCT00918281
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses), Quintiles, Inc., i3 Statprobe

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, High Grade Gliomas, Lung Cancer, Head and Neck Cancer, Sarcoma, Renal Cell Carcinoma, Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluciclatide Injection
Arm Type
Experimental
Arm Description
Fluciclatide Injection
Intervention Type
Drug
Intervention Name(s)
Fluciclatide Injection
Other Intervention Name(s)
Fluciclatide, AH111585 (18F) Injection
Intervention Description
Fluciclatide Injection (AH111585 (18F) Injection)
Primary Outcome Measure Information:
Title
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.
Description
Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.
Time Frame
Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.
Secondary Outcome Measure Information:
Title
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.
Description
Safety was monitored throughout the duration of the subject's participation.
Time Frame
Up to 8 weeks post contrast administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Winick, Ph.D.
Organizational Affiliation
GE Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
101 Carnegie Center
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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