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

GlaxoSmithKline (GSK)

Status and phase

Terminated

Phase 1

Conditions

Cancer

Treatments

Radiation: ML10

Study type

Interventional

Funder types

Industry

Identifiers

NCT01476085

114238

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No 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.