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A Positron Emission Tomography (PET) Study to Evaluate 18FML10 as an Imaging Agent for Tumour Apoptosis


N/A
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Positron Emission Tomography (PET) Study to Evaluate 18FML10 as an Imaging Agent for Tumour Apoptosis


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Apoptosis imaging

Outcome Description:

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

Outcome Time Frame:

2.5 years

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United Kingdom: Ethics Committee

Study ID:

113236

NCT ID:

NCT01428440

Start Date:

December 2009

Completion Date:

July 2011

Related Keywords:

  • Cancer

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