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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

About this trial

This is an interventional diagnostic trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT01476085

First Posted

September 1, 2011

Last Updated

June 27, 2013

Sponsor

GlaxoSmithKline

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

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

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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