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

NCT01302821 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-02-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Adenovirus-p53 transduced dendritic cell vaccine

The Ad.p53 DC vaccine will be injected intradermally (through the skin) into four separate sites. The patient's vaccine will be the same dose throughout the study.

DRUG

1-methyl-D-tryptophan

Each treatment cycle is comprised of 21 days. The treatment is continuous with no breaks in between cycles. Patients would not be allowed to take any tryptophan containing supplements while participating on this study.

RADIATION

Carbon C 11 alpha-methyltryptophan

The experimental examination for this research is the administration by a needle in a vein of Tryptophan labeled with a radioactive tracer (a substance is believed to enhance imaging for easier detection and measurement), Carbon 11, when when the patient has not eaten for five hours. A standard PET/CT scanner is then used to create images of the tracer a few minutes later.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Hatem Soliman, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01302821 on ClinicalTrials.gov