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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vaccine Therapy and 1-MT in Treating Patients With Metastatic Breast Cancer

NCT01042535

Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer +1 more

COMPLETED PHASE1/PHASE2

A Prospective, Multicenter, Observational Cohort Study to Evaluate the Efficacy and Safety of a Novel Anti-tumor Drug As a Radiosensitizer in Patients with Advanced Breast Cancer Brain Metastasis.

NCT06839547

Advanced Breast Cancer Brain Metastasis

NOT_YET_RECRUITING

BP-C1 in Metastatic Breast Cancer Patients

NCT01861509

Metastatic Breast Cancer Stage IV Breast Cancer

COMPLETED PHASE1

Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer

NCT07021911

Breast Cancer Radiotherapy; Complications

RECRUITING

Brain Irradiation and Tremelimumab in Metastatic Breast Cancer

NCT02563925

Metastatic Breast Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radiotherapy

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.

Group Type EXPERIMENTAL

Adenovirus-p53 transduced dendritic cell vaccine

Intervention Type BIOLOGICAL

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.

1-methyl-D-tryptophan

Intervention Type DRUG

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.

Carbon C 11 alpha-methyltryptophan

Intervention Type RADIATION

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

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.

Intervention Type DRUG

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.

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ad.p53 DC vaccine Advexin NSC 721782 1-MT radioactive tracer

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.