This trial is active, not recruiting.

Conditions breast cancer, head and neck cancer, prostate cancer
Treatment novel pet tracer facbc
Sponsor Memorial Sloan Kettering Cancer Center
Start date April 2006
End date April 2016
Trial size 20 participants
Trial identifier NCT00605488, 06-040


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Pet Scan
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.

Primary Outcomes

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

Secondary Outcomes

To compare these FACBC data with PET imaging findings using the current clinical standard PET tracer FDG.
time frame: conclusion of study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study Investigating the Biodistribution and Potential Diagnostic Ability of 18F FACBC in Patients With Head and Neck, Breast, and Prostate Cancer
Principal investigator Heiko Schöder, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.