Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)
Primary Purpose
Cancer
Status
Terminated
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ML10
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
- 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
- A female subject is eligible to participate if she has non-childbearing potential
- Male subject must agree to use one of the contraception methods listed
- Able to lie comfortably on back for up to 70 minutes at a time.
- WHO performance status 0, 1 or 2 -
Exclusion Criteria:
- Patients with known history of Hepatitis B, C, non-A, non-B and HIV
- Any clinically significant medical conditions that in the opinion of the investigator would compromise the compliance with study procedures.
- Pregnant or breast feeding females.
- Any other prior anticancer therapy
- Any new investigational agent, including an investigational anti-cancer agent
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
Males and females not able to comply with contraceptive guidelines during the study.
-
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
no treatment
Arm Description
no treatment
Outcomes
Primary Outcome Measures
changes in [18F]ML10 uptake in tumours
Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.
Secondary Outcome Measures
alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes
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.
voxel-based uptake map of [18F]ML10 in the target lesion
Alterations in the voxel-based uptake map of [18F]ML10 in the target lesion in response to the chemotherapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01476085
Brief Title
Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)
Official Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Study terminated as ongoing analysis suggested objectives not practical to achieve with study as implemented
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no treatment
Arm Type
No Intervention
Arm Description
no treatment
Intervention Type
Radiation
Intervention Name(s)
ML10
Intervention Description
[18F]ML10 radioligand apoptosis biomarker
Primary Outcome Measure Information:
Title
changes in [18F]ML10 uptake in tumours
Description
Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.
Time Frame
between baseline at day 0 and between 14-20 days after
Secondary Outcome Measure Information:
Title
alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes
Description
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.
Time Frame
between baseline at day 0 and between 14-20 days after
Title
voxel-based uptake map of [18F]ML10 in the target lesion
Description
Alterations in the voxel-based uptake map of [18F]ML10 in the target lesion in response to the chemotherapy.
Time Frame
between baseline at day 0 and between 14-20 days after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
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
A female subject is eligible to participate if she has non-childbearing potential
Male subject must agree to use one of the contraception methods listed
Able to lie comfortably on back for up to 70 minutes at a time.
WHO performance status 0, 1 or 2 -
Exclusion Criteria:
Patients with known history of Hepatitis B, C, non-A, non-B and HIV
Any clinically significant medical conditions that in the opinion of the investigator would compromise the compliance with study procedures.
Pregnant or breast feeding females.
Any other prior anticancer therapy
Any new investigational agent, including an investigational anti-cancer agent
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Males and females not able to comply with contraceptive guidelines during the study.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)
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