None listed
Conditions
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.
Interventions
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.
Sponsors
Royal Brisbane and Women's Hospital Research Advisory Committee
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed