PET Study to Study Tumour Apoptosis

NCT01428440 | Terminated Phase 2

• 1 other identifier: 113236
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

Apoptosis or programmed cell death is disrupted in cancer cells allowing them to live longer. A number of anti-cancer agents induce apoptosis as a mechanism of drug action to get rid of cancers. A biomarker that would allow apoptosis in tumours to be imaged directly would provide a powerful new tool for oncology drug development and potentially contribute to improved patient care. In this study, we propose to evaluate \[18F\]ML10-PET for imaging tumour apoptosis in patients receiving standard chemotherapy treatment for their cancer.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Apoptosis imaging

  Evaluate feasibility of apoptosis imaging with \[18F\]ML10 PET/CT in

  2.5 years

Secondary Outcomes (5)

• [18F]ML10 tumour uptake

  2.5 years

• Image optimisation time

  2.5 years

• Develop Imaging protocols

  2.5 years

• serum markers

  2.5 years

• Oncology patients

  2.5 years

Study Arms (1)

no treatment

OTHER

Radiation: 18FML10

Interventions

18FML10 RADIATION

apoptosis imaging radio ligand

no treatment

Eligibility Criteria

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

You may qualify if:

• Male or female patients \>18 years of age at screening with histological or cytological diagnosis of non-Hodgkin's lymphoma, small cell lung cancer, breast or ovarian cancer who have been worked up clinically (see below) and due to receive standard chemotherapy treatment, but enrolled prior to the initiation of chemotherapy.
• A female subject is eligible to participate if she is of non-childbearing potential or if she is of childbearing potential and agrees to use one of the contraception methods listed. Male subjects are eligible to participate if he also agrees to use one of the contraception methods listed.
• Tumour that is considered by the investigator to be able to be imaged using PET (about 2cm in size or more)
• Able to lie comfortably on back for up to 65 minutes at a time.
• Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
• Patients deemed to be fit to receive chemotherapy treatment by their oncologist.
• WHO performance status 0, 1 or 2.

You may not qualify if:

• Any medical or psychiatric diagnoses or symptoms or social situations that in the view of the investigator would limit compliance with study requirements.
• Pregnant or breast feeding females.
• Received any other anticancer therapy (radiotherapy, chemotherapy, or immunotherapy) or any other investigational agent, including an investigational anti-cancer agent within 28 days prior to the first \[18F\]ML10-PET scan.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• Inability to comply with contraceptive guidelines during the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Imperial College London: collaborator

Study Sites (2)

GSK Investigational Site

London, London, W12 0NN, United Kingdom

Location

GSK Investigational Site

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: September 5, 2011
• Study Start: December 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

GB (2)