Tumor hypoxia measured with F-MISO-PET in the course of irradiation of head and neck cancer: adoption of the method into clinical routine and evaluation of the data

Tumor hypoxia measured with F-MISO-PET in the course of irradiation of head and neck cancer: adoption of the method into clinical routine and evaluation of the data - F-MISO-R

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00006007

Enrollment

Registered

2014-07-14

Start date

2014-09-09

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

C10 C13

Interventions

Group 1: 18F FMISO PET before radiotherapy and after 2 weeks radiotherapy and additional blood analysis at both imaging timepoints

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: • age 18-70 years • inoperable histological confirmed head and neck cancer (squamous cell carcinoma of the pharynx, oral cavity and supraglottis) • general condition WHO 0-2 • tumor volume and location permit curative radiotherapy

Exclusion criteria

Exclusion criteria: • distant metastases • previous irradation in the head and neck region • second carcinoma except T1 skin cancer and in-Situ-carcinoma of the cervix uteri • pregnancy • lack of understanding or lack of cooperation

Design outcomes

Primary

Measure	Time frame
Local progression free survival in case of residual hypoxia (measured as TBRmax > 1.9) after 20Gy radio-chemotherapy. This is measured two years after completion of treatment, a so-called 2-year local progression-free survival. The data of residual hypoxic versus non-hypoxic patients are evaluated according to the Cox proportional hazard model as a comparison of the survival curves.	—

Secondary

Measure	Time frame
Further evaluation of oncologic parameters: Overall survival, local control, progression free survival. These are checked after 2 and 5 years. Furthermore measure quality of life and correlation with dosimetric parameters. To measure quality of life, the established EORTC-QLQ-C30 and HN35 sheets are used. The sheets are handed out to the patients before therapy, and twice shortly after the end of treatment. Subsequently once a year to five years after the end of treatment. In addition a correlation of hypoxia markers from blood samples to be taken and FMISO PET parameters and oncological parameters takes place.	—

Measure

Time frame

Further evaluation of oncologic parameters: Overall survival, local control, progression free survival. These are checked after 2 and 5 years. Furthermore measure quality of life and correlation with dosimetric parameters. To measure quality of life, the established EORTC-QLQ-C30 and HN35 sheets are used. The sheets are handed out to the patients before therapy, and twice shortly after the end of treatment. Subsequently once a year to five years after the end of treatment. In addition a correlation of hypoxia markers from blood samples to be taken and FMISO PET parameters and oncological parameters takes place.

—

Countries

Germany

Contacts

Public ContactAnnett Klöber

Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum

str.studien@uniklinikum-dresden.de0351-458 13390

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026