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Pilot Study Investigating the Biodistribution and Potential Diagnostic Ability of 18F FACBC in Patients With Head and Neck, Breast, and Prostate Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Head and Neck Cancer, Prostate Cancer

Thank you

Trial Information

Pilot Study Investigating the Biodistribution and Potential Diagnostic Ability of 18F FACBC in Patients With Head and Neck, Breast, and Prostate Cancer


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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.

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Heiko Schöder, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-040

NCT ID:

NCT00605488

Start Date:

April 2006

Completion Date:

April 2013

Related Keywords:

  • Breast Cancer
  • Head and Neck Cancer
  • Prostate Cancer
  • Pet Scan
  • Breast Neoplasms
  • Head and Neck Neoplasms
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021