Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET

August 28, 2017 updated by: Columbia University

The goal of this research study is to learn if a new type of PET scan (18F-FLT) can help to better detect changes of tumor growth rate (or how active) in esophagus cancer and lung cancer Researchers will study at what time during treatment the 18F-FLT PET scan should be given to get the best results. A Positron Emission Tomography (PET) scan is a type of scan that uses a radioactive solution to locate cancer cells inside the body. Using the PET scan, doctors can locate solid tumors and collect information about how "active" the cancer cells are. For this study, a new type of solution, [F-18]-fluoro-L-thymidine (FLT), will be used. FLT can detect actively growing tumor, and researchers hope that FLT may be able to help provide information about how well esophagus cancer treatment is working. This information could be used to help predict if the cancer will respond to treatment.

All enrolled subjects will receive PET/CT imaging at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy (3 weeks from the start of Neoadjuvant Therapy) prior to the surgery. At each time of the PET/CT procedure, the subject will receive an injection of FLT which is an investigational pharmaceutical labeled with radioactive fluorine. 45-60 mines after the FLT injection, the scan will be performed. Each scan might take 10-15 minutes. Participation in this pilot study will not change the patients normal chemotherapy, radiation treatment, and surgery recommended the patients physician as parts of their standard of care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of the study is to obtain preliminary data and initial estimates of the FLT ability-PET to identify pathCR patients who have esophageal carinoma or non-small cell lung cancer and undergo Neoadjuvant Therapy (Chemoradiotherapy, Chemotherapy or Radiation Therapy) prior to surgery. Achievement in pathCR after pre-operative Neoadjuvant Therapy is associated with improved patient outcomes; however, there is no effective method to predict pathological response before surgery. Thus, a patient with pathCR , for whom esophagectomy or thoracoscopy may be unnecessary, still undergoes surgery and faces the prohibitive side effects of this surgical procedure. Additionally, Neoadjuvant Therapy is associated with considerable morbidities and tool to predict and avoid ineffective therapy are lacking. Because deregulated proliferation is one of the hallmarks of cancer and its proliferation rate is associated with aggressive biologic behavior and response to therapy, imaging the proliferative state of cancer cells by non-invasive functional imaging is of great interest. Recently 18F-FLT (3'deoxy33'-18F- fluorothymidine) has been reported as a promising PET radiopharmaceutical for imaging cancer proliferation and has been validated in several in vitro & in vivo models. However, only a few studies addressed its role in depicting changes in cancer proliferation and assessing response to Neoadjuvant Therapy, and none of these studies have focused on esophageal cancer and lung cancer. We propose to conduct a pilot study to learn the optimal FLT PET imaging timepoint during the early course of Neoadjuvant Therapy that has the highest predictive value for pathCR in patients with esophageal cancer or lung cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with histologically diagnosed adenocarcinoma or squamous cell carcinoma of the esophagus and locoregional disease (stages II and III) and locally advanced non-small cell lung cancer (stage III) will be eligible for participation in this study.

Exclusion Criteria:

  • Abnormal liver function (<2.5 x ULN of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ; <1.5 x upper limit of normal (ULN) of bilirubin total) or abnormal renal function (<1.5 x ULN of creatinine) or peripheral neuropathy
  • Women with pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Fluoro-L-Thymidine
Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery.
Drug: Fluoro-L-Thymidine
4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.
Other Names:
  • FLT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Optimal Timepoint During the Course of Neoadjuvant Therapy [CRT, CT (Chemotherapy) or RT Radiotherapy)] That FLT-PET Imaging Can Predict Response
Time Frame: 2.5 months
2.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: K.S. Clifford Chao, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAD5444
  • R21CA121551 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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