Detection of hypoxia (low oxygen) in lung cancer using imaging

Detection of hypoxia in non small cell lung carcinoma with [18F]FAZA-PET and [18F]FMISO-PET

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18092347

Enrollment

Registered

2018-08-07

Start date

2018-03-26

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer Cancer

Interventions

The study will recruit 20 patients in total. The first 10 patients will undergo a test-retest with [18F]FAZA PET, with an initial [18F]FAZA scan, followed by a subsequent [18F]FAZA scan at an interval

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histopathological confirmation of a diagnosis of non small cell lung cancer 2. Reasonable performance status (WHO performance status 0-1) 3. Medically fit and eligible for curative surgical resection or radical chemoradiotherapy 4. Able to give informed consent

Exclusion criteria

Exclusion criteria: 1. Diagnosis of small cell lung cancer (SCLC) 2. WHO performance status of =2 3. Pregnant 4. Required to start treatment as an emergency (within 7 days) 5. Not suitable for surgical resection or radical chemoradiotherapy

Design outcomes

Primary

Measure	Time frame
The primary outcome measure will be to assess the reproducibility of the hypoxia PET/CT images with time as the only variable. Several metrics will be used to assess uptake, including Standardised Uptake Values (SUV), Tumour to Blood ratio (TBR) and Fractional Hypoxic volume (FHV). Reproducibility will be assessed by correlation between the values obtained for the two scans performed in each patient and an assessment of the voxel distribution and spatial correlation between the two scans will also be performed.	—

Measure

Time frame

The primary outcome measure will be to assess the reproducibility of the hypoxia PET/CT images with time as the only variable. Several metrics will be used to assess uptake, including Standardised Uptake Values (SUV), Tumour to Blood ratio (TBR) and Fractional Hypoxic volume (FHV). Reproducibility will be assessed by correlation between the values obtained for the two scans performed in each patient and an assessment of the voxel distribution and spatial correlation between the two scans will also be performed.

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Secondary

Measure	Time frame
1. Correlation of SUV, TBR and FHV calculated by imaging with intrinsic hypoxia biomarkers by immunohistochemistry analysis of HIF1alpha and CAIX (Carbonic Anhydrase IX), expressed as a percentage and correlation performed with the metrics for uptake values for each scan. 2. Comparison of FAZA and FMISO images and reproducibility will be assessed by comparison of the degree of reproducibility as assessed by the above measures in the primary outcome 3. Optimisation of FAZA and FMISO imaging protocols will be performed during the clinical trial by assessment of the various uptake values and imaging parameters and the information obtained at each time point (dynamic and static) of the imaging protocol 4. Overall survival (months) will be obtained for each patient in order that an assessment can be made of the correlation between tracer uptake, as measured above, and overall survival in months	—

Measure

Time frame

1. Correlation of SUV, TBR and FHV calculated by imaging with intrinsic hypoxia biomarkers by immunohistochemistry analysis of HIF1alpha and CAIX (Carbonic Anhydrase IX), expressed as a percentage and correlation performed with the metrics for uptake values for each scan. 2. Comparison of FAZA and FMISO images and reproducibility will be assessed by comparison of the degree of reproducibility as assessed by the above measures in the primary outcome 3. Optimisation of FAZA and FMISO imaging protocols will be performed during the clinical trial by assessment of the various uptake values and imaging parameters and the information obtained at each time point (dynamic and static) of the imaging protocol 4. Overall survival (months) will be obtained for each patient in order that an assessment can be made of the correlation between tracer uptake, as measured above, and overall survival in months

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Countries

Scotland, United Kingdom

Contacts

Public ContactKirsten Laws

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026