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Completed

NCT Number: NCT00918281

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

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.

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Key information

Conditions

Solid Tumors Adenocarcinoma Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Head and Neck Cancer Head and Neck Neoplasms High Grade Gliomas Kidney Diseases Kidney Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

101 Carnegie Center

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluciclatide Injection

Drug

Fluciclatide Injection (AH111585 (18F) Injection)

Other names: Fluciclatide, AH111585 (18F) Injection

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.

    Time frame: Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.

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

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.

    Time frame: Up to 8 weeks post contrast administration.

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

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses)
  • Quintiles, Inc.
  • i3 Statprobe

Registry information

Official study title

A Test-retest Study to Assess Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of AH111585 (18F) Injection.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 11, 2009
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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