C11 AMT Positron Emission Tomography (PET) Imaging in Patients With Metastatic Invasive Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Biological: Adenovirus-p53 transduced dendritic cell vaccine; Radiation: Carbon C 11 alpha-methyltryptophan; Drug: 1-methyl-D-tryptophan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01302821

MCC-16216 (Other Identifier)

NCI 8701

Details and patient eligibility

About

The purpose of this research project is to create images of where and how the amino acid (the building blocks of proteins)Tryptophan is processed in normal and abnormal tissue in the patient's body. Tryptophan is a normal building block of proteins in the body. Sometimes in the case of cancer and other diseases, Tryptophan is processed abnormally, and possible treatments for this abnormality are of great interest because of the potential to improve cancer care.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Radiotherapy

Experimental group

Description:

AMT positron emission tomography with integrated computed tomography (PET/CT)scanning in metastatic breast cancer patients to identify tumors with increased AMT uptake due to up-regulated IDO expression.

Treatment:

Radiation: Carbon C 11 alpha-methyltryptophan

Drug: 1-methyl-D-tryptophan

Biological: Adenovirus-p53 transduced dendritic cell vaccine