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The Biodistribution and Potential Diagnostic Ability of 18F FACBC in Patients With Head and Neck, Breast, and Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00605488
First received: January 17, 2008
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

See where the dye-like material (FACBC) goes in your body and how long it stays in your body. See how much of the dye-like material is picked up by your tumor Compare the FACBC pictures with other pictures (such as FDG PET scan) that were obtained as part of your standard imaging evaluation.


Condition Intervention
Breast Cancer
Head and Neck Cancer
Prostate Cancer
 Procedure: novel PET tracer FACBC

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study Investigating the Biodistribution and Potential Diagnostic Ability of 18F FACBC in Patients With Head and Neck, Breast, and Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To study the biodistribution and dosimetry of FACBC in patients with head and neck squamous cell carcinoma (HNSCC), breast cancer and prostate cancer. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare these FACBC data with PET imaging findings using the current clinical standard PET tracer FDG. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2006
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pet Scan
 Procedure: novel PET tracer FACBC
Two IV catheters (heplock) will be placed in your forearms for injection of the dye-like material (FACBC) and blood sampling. An IV blood sample and a urine sample will be taken for testing. These samples will be used to measure the dye, FACBC, in blood and urine. You will be placed in the PET machine, where FACBC will be injected slowly over 30 seconds. Pictures of one region of your body will be taken for up to 60 minutes. Depending on your condition, your actual picture time may be shorter. You will come out of the scanner to stretch, walk around or sit in a chair. An optional urine sample and an IV blood sample will also be taken at this time. Again, these samples will be used to measure the dye, FACBC, in blood and urine. This will be followed by a picture of your body from the neck to the upper thighs. This picture will take about 30 minutes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ or equal 18 years old
  • Scheduled for treatment at Memorial Hospital
  • Primary HNSCC or primary breast cancer; histological confirmation of diagnosis at Memorial hospital
  • Large primary HNSCC cancer (loco-regional advanced, ≥ or equal to T2) by CT/MRI imaging or clinical exam, without prior treatment, N1-N3
  • Large primary breast cancer (≥ or equal to T2) by imaging or clinical impression based physical exam; patients with suspicion of axillary nodal disease (N1-2), without prior treatment
  • Established progressive metastatic prostate cancer
  • This diagnosis may be based upon histologic confirmation of metastatic disease by biopsy of a lesion OR clear clinical evidence for metastatic disease (e.g., based on clinical findings, laboratory data and/or imaging findings in CT, MRI, or bone scan), as defined by the referring oncologist
  • Progressive disease is defined as clear progression on imaging studies (increase in size and number of lesions on bone scan, CT, or MRI) and consecutive rises in PSA as used in clinical management by the prostate cancer oncology group at MSKCC
  • FDG PET scan was obtained as part of the clinical work-up, within 4 weeks prior to enrollment. This clinical FDG PET scan should be done at MSKCC.
  • Disease can be clearly demonstrated by structural imaging (CT or MRI) or bone scan. This may include characteristic bone lesions on bone scan, CT or MRI; AND/OR measurable soft tissue/nodal lesions on CT or MRI.
  • Minimum tumor/metastasis size of 1 cm
  • Negative pregnancy test

Exclusion Criteria:

  • Patient cannot tolerate lying still for approximately 60 minute sessions in the PET tomograph.
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605488

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Heiko Schöder, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00605488     History of Changes
Other Study ID Numbers: 06-040
Study First Received: January 17, 2008
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Pet Scan

Additional relevant MeSH terms:
Breast Neoplasms
Head and Neck Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013