Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001379707
Ethics application status
Approved
Date submitted
4/12/2013
Date registered
16/12/2013
Date last updated
16/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Prognostic Value of Assessing Hypoxia in Tumours Using 18FMISO PET During a Course of Radiation Therapy – Proof of Concept Study
Scientific title
Prognostic Value of Assessing Hypoxia in Cervical and Lung Tumours Using 18FMISO PET During a Course of Radiation Therapy – Proof of Concept Study
Secondary ID [1] 283688 0
Nil known
Universal Trial Number (UTN)
U1111-1150-9948
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxia in cancer 290651 0
Condition category
Condition code
Cancer 291029 291029 0 0
Cervical (cervix)
Cancer 291030 291030 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three study FMISO-CT/PET scans. Timing of scans is pre-treatment, after 10 fraction and 2 weeks after completion of radiotherapy treatment.
Each FMISO-PET/CT scan will take approximately 60 minutes. A needle (intravenous cannula) is inserted into the patients arm and used to inject the contrast for this scan.
Intervention code [1] 288388 0
Diagnosis / Prognosis
Comparator / control treatment
Patients sequential scans are compared to their baseline scan.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291017 0
Evaluate the feasibility of measuring the changes in hypoxia as assessed by FMISO-PET within the tumour throughout a course of radical chemoradiation therapy.

The level of hypoxia is measured and assessed using image analysis software in the Nuclear medicine department. It measure levels of radioactivity that FMISO produces. The feasibility assessment is to ensure that we can adequately measure the changes and the images will be analysable with their software. Other software will need to be explored if this doesn't work.
Timepoint [1] 291017 0
After completion of the three study scans.
Secondary outcome [1] 305850 0
Evaluate the textural analysis method in hypoxia PET imaging.

This is performed using Matlab software and allows additional information to be obtained from the PET scans. It is hoped this will provide a semi-quantitative measuring tool.
Timepoint [1] 305850 0
After completion of the three study scans.

Eligibility
Key inclusion criteria
Cervical Cancer:
FIGO 2008 stage IB1 & node positive, IB2, II, IIIB or IVA disease.
Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix

NSCLC:
IASLC stage 2B to 3B.
Subject must have cytologically or histologically confirmed NSCLC

All participants:
Age >/= 18 years of age
ECOG performance status 0-2
Adequate bloods and renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any prior radiotherapy to the same area.
Previous chemotherapy for the cancer.
Evidence of distant metastases
Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
Serious medical or psychiatric conditions that might compromise management according to the protocol.
Inability to comply with all study requirements
Pregnancy, lactation, or inadequate contraception.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients will receive standard of care treatment, with the addition of 3 FMISO PET scans.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Feasibility study, 10 participants

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/01/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1789 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 7606 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 288375 0
Hospital
Name [1] 288375 0
Research Advisory Committee, Royal Brisbane and Women's Hospital
Country [1] 288375 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital Research Advisory Committee
Address
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 287078 0
None
Name [1] 287078 0
Address [1] 287078 0
Country [1] 287078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290254 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 290254 0
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 290254 0
Australia
Date submitted for ethics approval [1] 290254 0
Approval date [1] 290254 0
23/08/2013
Ethics approval number [1] 290254 0
HREC/13/QRBW/147

Summary
Brief summary
This study will evaluate the prognostic value of assessing hypoxia (low oxygen) in cervical and lung tumours using FMISO-CT/PET scans throughout a course of radical chemoradiation therapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with either cervical cancer or non-small cell lung cancer (NSCLC), for which your are scheduled to undergo a course of radical radiation therapy with or without chemotherapy. You should not have received any previous radiotherapy or chemotherapy for the cancer, or have any evidence of distant metastases. Study details All participants in this study will be treated as per standard of care with the addition of 3 FMISO-PET scans which will be done prior to treatment (baseline), 2 weeks into radiation therapy and 2 weeks after completion of radiotherapy. Each FMISO-PET/CT scan will take approximately 60 minutes. During this time an intravenous cannula will be inserted into your arm and contrast injected. PET scans pose a small health risk as they involve exposure to radiation. The dose from this study is comparable to that received from many diagnostic medical x-ray and nuclear medicine procedures. The aim in this proof of concept study is to demonstrate that we can non-invasively and safely use 18FMISO-PET on 2 cohorts of patients (cervix and non-small cell lung(NSCLC)) whose tumours are known to be affected by hypoxia and explore the tools to measure the PET images to objectively evaluate the hypoxic region within the tumour throughout a course of radiation therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44714 0
Dr Philip Chan
Address 44714 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 44714 0
Australia
Phone 44714 0
+61 7 3646 7687
Fax 44714 0
Email 44714 0
[email protected]
Contact person for public queries
Name 44715 0
Dr Philip Chan
Address 44715 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 44715 0
Australia
Phone 44715 0
+ 61 7 3646 7687
Fax 44715 0
Email 44715 0
[email protected]
Contact person for scientific queries
Name 44716 0
Dr Philip Chan
Address 44716 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 44716 0
Australia
Phone 44716 0
+ 61 7 3646 7687
Fax 44716 0
Email 44716 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.