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NCI 8701: A Pilot Study Utilizing C11 Alpha Methyl Tryptophan (AMT) PET Functional Imaging in Patients With Metastatic Invasive Breast Cancer Treated With 1 Methyl D Tryptophan Plus the Ad p53 DC Vaccine


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

NCI 8701: A Pilot Study Utilizing C11 Alpha Methyl Tryptophan (AMT) PET Functional Imaging in Patients With Metastatic Invasive Breast Cancer Treated With 1 Methyl D Tryptophan Plus the Ad p53 DC Vaccine


Coordinating Center: Southeast Phase 2 Consortium (SEP2C), Moffitt Cancer Center.

Research participation involves up to three experimental imaging examination visits in
radiology: a baseline before the patient starts a cancer treatment, a follow-up a few days
later, and a later follow up to see how the treatment may affect normal or abnormal
processing of Tryptophan.

The research imaging results will be linked with other evidence of the patient's disease,
but will not effect their care.


Inclusion Criteria:



- Patients must be enrolled on the NCI 8461/MCC 16025 study.

- Consent for participation in this companion imaging study and be able to successfully
complete a minimum of two AMT PET/CT scans.

Exclusion Criteria:

- Patients must not meet any of the exclusion criteria for the NCI 8461/ MCC 16025
study.

- Not have any medical conditions prohibiting the successful completion of a minimum of
two AMT PET/CT scans.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Occurrence of Detected Changes in Regions of Interest (ROIs)

Outcome Description:

Changes in C-11 AMT uptake and localization (measured by SUV) between baseline and approximately 4 days after initiation of treatment. The primary objective is to determine whether such changes can be detected in regions of interest (ROIs) using PET/CT imaging in patients with metastatic breast cancer enrolled in NCI 8461/ MCC16025. The SUV values in identified regions of interest (ROIs) for each patient will be compared over time between baseline and approximately 4 days after initiation of treatment, and after completion of the protocol treatment. The analysis will be largely exploratory and descriptive as the sample size and study design will likely preclude an adequate/definitive statistical conclusion of SUV values between the two time points.

Outcome Time Frame:

Average of 7 weeks

Safety Issue:

No

Principal Investigator

Hatem Soliman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

NCI 8701

NCT ID:

NCT01302821

Start Date:

August 2013

Completion Date:

April 2014

Related Keywords:

  • Breast Cancer
  • breast - male
  • breast - female
  • metastatic
  • invasive
  • Breast Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612