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

NCT01476085 | Terminated Phase 1

• 1 other identifier: 114238
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes

  between baseline at day 0 and between 14-20 days after

• voxel-based uptake map of [18F]ML10 in the target lesion

  between baseline at day 0 and between 14-20 days after

Study Arms (1)

no treatment

NO INTERVENTION

no treatment

Radiation: ML10

Interventions

ML10 RADIATION

\[18F\]ML10 radioligand apoptosis biomarker

no treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: November 22, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 1, 2013

Record last verified: 2013-06

Locations

GB (1)