NCT00918281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 9, 2014

Completed
Last Updated

June 9, 2014

Status Verified

June 1, 2014

Enrollment Period

2.3 years

First QC Date

June 9, 2009

Results QC Date

October 23, 2013

Last Update Submit

June 6, 2014

Conditions

Solid TumorsHigh Grade GliomasLung CancerHead and Neck CancerSarcomaRenal Cell CarcinomaBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.

Secondary Outcomes (1)

  • 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.

    Up to 8 weeks post contrast administration.

Study Arms (1)

Fluciclatide Injection

EXPERIMENTAL

Fluciclatide Injection

Drug: Fluciclatide Injection

Interventions

Fluciclatide InjectionDRUG

Fluciclatide Injection (AH111585 (18F) Injection)

Also known as: Fluciclatide, AH111585 (18F) Injection
Fluciclatide Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

101 Carnegie Center

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsHead and Neck NeoplasmsSarcomaCarcinoma, Renal CellBreast Neoplasms

Interventions

AH 111585Injections

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Matthew Miller
Organization
GE Healthcare
matthew.miller@ge.com
011-44-1494-543981

Study Officials

  • Jeffrey Winick, Ph.D.

    GE Healthcare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 11, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

June 9, 2014

Results First Posted

June 9, 2014

Record last verified: 2014-06

Locations

US(1)