Evaluation of 18F-MISO-PET detectable changes in proliferation and dispersion of hypoxic subvolume in head and neck cancer in patients undergoing radio(chemo)therapy

Conditions

Squamous cell carcinoma of the head and neck C01 C04 C09 C10 C13 C32

Kafkaletos A, Sachpazidis I, Mix M, Carles M, Stoian R, Schäfer H, Bock M, Baltas D, Grosu AL.

2025-09-01

10.1186/s13014-025-02716-6

The significance of partial volume effect on the estimation of hypoxic tumour volume with [<sup>18</sup>F]FMISO PET/CT.

Kafkaletos A, Mix M, Sachpazidis I, Carles M, Rühle A, Ruf J, Grosu AL, Nicolay NH, Baltas D.

2024-05-093 citations

10.1186/s40658-024-00643-1

Interleukin-6 as surrogate marker for imaging-based hypoxia dynamics in patients with head-and-neck cancers undergoing definitive chemoradiation-results from a prospective pilot trial.

Rühle A, Wiedenmann N, Fennell JT, Mix M, Ruf J, Stoian R, Thomsen AR, Vaupel P, Baltas D, Grosu AL, Nicolay NH.

2021-11-134 citations

10.1007/s00259-021-05602-x

Convolutional neural networks for head and neck tumor segmentation on 7-channel multiparametric MRI: a leave-one-out analysis

Lars Bielak, Nicole Wiedenmann, Arnie Berlin, Nils H. Nicolay, Deepa Darshini Gunashekar et al. (9 authors)

Radiation Oncology2020-07-2931 citations

10.1186/s13014-020-01618-z

Effect of radiochemotherapy on T2* MRI in HNSCC and its relation to FMISO PET derived hypoxia and FDG PET.

Wiedenmann N, Bunea H, Rischke HC, Bunea A, Majerus L, Bielak L, Protopopov A, Ludwig U, Büchert M, Stoykow C, Nicolay NH, Weber WA, Mix M, Meyer PT, Hennig J, Bock M, Grosu AL.

2018-08-2925 citations

10.1186/s13014-018-1103-1

Interventions

Group 1: 33 patients should have a combined PET before the start of therapy. The changes of hypoxic subvolumes in the tumors will be recorded in further 2 PET in therapy week 2 and 5.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Histo - or cytologically secured squamous cell carcinoma of the oral cavity, hypopharynx or larynx • Stage III / IV (M0) • ECOG performance status 0 or 1 • Two-dimensionally measurable tumor> = 2cm in at least one dimension • Age> = 18 years Adequate hematologic function • (Hb> 9 g / dl, platelets> = 100X 10 9 / l, ANC> = 1.5 X 10 9 / L) • Adequate renal function (creatinine - clearance> = 50 ml / min) • Adequate liver function (AST, ALT and total bilirubin = LLN) • Written consent

Exclusion criteria

Exclusion criteria: Previous anti-EGFR antibody therapy or treatment with small molecule tyrosine kinase inhibitors • Previous surgery, chemotherapy or radiation for in the relevant study malignancies • Prophylactic tracheostomy • Other known clinically significant diseases (cardiovascular, pulmonary, infections such as HIV, HCV, HBV, ...) • Pregnant or lactating women • To provide each type of disability, which affects the compliance or ability of the patient, written consent

Design outcomes

Primary

Measure	Time frame
- changes in PET detected tumor hypoxia in week 0, week 2 and week 5 of radiochemotherapy by evaluation of SUV and hypoxic subvolumes - changes in MRT detected perfusion, diffusion and oxygenation in week 0, week 2 and week 5 of radiochemotherapy by evaluation of ADC, ktrans	—

Secondary

Measure	Time frame
- Clinical Follow-ups in addition to radiographic diagnostic to determine overall survival, local tumour control, distant metastasis; point of time: every 3 months in the first 2 years and controls in form of routine follow ups for 5 years - comparison of 3-Tesla-MRI and FMISO-PET/CT scans to establish methods for defining hypoxic subvolumes	—

Countries

Germany

Contacts

Public ContactNils H. Nicolay

Klinik für Strahlenheilkunde

nils.nicolay@uniklinik-freiburg.de0761/27095200

Outcome results

None listed