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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, 2014
Last verified: October 2014

January 17, 2008
October 29, 2014
April 2006
April 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00605488 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Biodistribution and Potential Diagnostic Ability of 18F FACBC in Patients With Head and Neck, Breast, and Prostate Cancer
Pilot Study Investigating the Biodistribution and Potential Diagnostic Ability of 18F FACBC in Patients With Head and Neck, Breast, and Prostate Cancer

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Breast Cancer
  • Head and Neck Cancer
  • Prostate Cancer
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.
Experimental: 1
Pet Scan
Intervention: Procedure: novel PET tracer FACBC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00605488
06-040
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Heiko Schöder, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP