Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)

June 27, 2013 updated by: GlaxoSmithKline

An Open-label Study to Evaluate the Utility of the Apoptosis Imaging Biomarker 18F]ML10 to Assess the Response to Chemotherapy in Patients With Non-Hodgkin's Lymphoma(NHL).

This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma.

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

Apoptosis or programmed cell death mechanisms are disrupted in cancer cells allowing them to live longer and grow faster than normal cells. Apoptosis is a key target for several novel anti-cancer agents. A biomarker that could permit imaging levels of ongoing apoptosis could be a powerful tool in associated drug development programs by providing relevant data to support proof of concept. In addition, use in the clinical setting may permit the tailoring of treatment for individual patients balancing efficacy of treatment with known toxicity levels. This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma. All patients will have a baseline [18F]ML10 PET-CT scan and a post-treatment scan after the initiation of the first course of intravenous chemotherapy. The study aims to enrol unto 16 subjects with Non-Hodgkins Lymphoma.

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.
1

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.
  • Phase 1

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 Kingdom
      • London, United Kingdom, W12 0NN
        • GSK Investigational Site

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:

  1. Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
  2. Male or female patients >18 years of age at screening with histological or cytological diagnosis of Non-Hodgkin's Lymphoma and due to receive intravenous chemotherapy for the first time
  3. A female subject is eligible to participate if she has non-childbearing potential
  4. Male subject must agree to use one of the contraception methods listed
  5. Able to lie comfortably on back for up to 70 minutes at a time.
  6. WHO performance status 0, 1 or 2 -

Exclusion Criteria:

  1. Patients with known history of Hepatitis B, C, non-A, non-B and HIV
  2. Any clinically significant medical conditions that in the opinion of the investigator would compromise the compliance with study procedures.
  3. Pregnant or breast feeding females.
  4. Any other prior anticancer therapy
  5. Any new investigational agent, including an investigational anti-cancer agent
  6. History of sensitivity to heparin or heparin-induced thrombocytopenia.

  7. Males and females not able to comply with contraceptive guidelines during the study.

    -

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
No Intervention: no treatment
Radiation: ML10
[18F]ML10 radioligand apoptosis biomarker

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
Measure Description
Time Frame
changes in [18F]ML10 uptake in tumours
Time Frame: between baseline at day 0 and between 14-20 days after
Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.
between baseline at day 0 and between 14-20 days after

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes
Time Frame: between baseline at day 0 and between 14-20 days after
Relationship between alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes in response to chemotherapy as measured by standard of care CT scan and FDG PET scan.
between baseline at day 0 and between 14-20 days after
voxel-based uptake map of [18F]ML10 in the target lesion
Time Frame: between baseline at day 0 and between 14-20 days after
Alterations in the voxel-based uptake map of [18F]ML10 in the target lesion in response to the chemotherapy.
between baseline at day 0 and between 14-20 days after

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.
GlaxoSmithKline

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.
July 1, 2011

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.
October 1, 2011

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.
October 1, 2011

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).
September 1, 2011

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.
November 17, 2011

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.
November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

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.
July 1, 2013

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.
June 27, 2013

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.
June 1, 2013

More Information

Terms related to this study

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.
  • 114238

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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