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

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: Terminated
• Conditions: Cancer
• Intervention / Treatment: Radiation: ML10

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: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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.

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: no treatment	Radiation: ML10; [18F]ML10 radioligand apoptosis biomarker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in [18F]ML10 uptake in tumours	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

Outcome Measure	Measure Description	Time Frame
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.	between baseline at day 0 and between 14-20 days after
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.	between baseline at day 0 and between 14-20 days after

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: September 1, 2011
• First Submitted That Met QC Criteria: November 17, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Estimate): July 1, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: 114238