18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study

National Cancer Centre, Singapore

Status: Completed

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: (18)F-fluoromisonidazole (FMISO)

Study type: Interventional

Funder types: Other

Identifiers

NCT04995185

MISSION16

Details and patient eligibility

About

This study aims to investigate the use of 18F-FMISO PET in identifying hypoxic subvolume for dose escalation radiotherapy in nasopharyngeal cancer and thus improve local control without significant increase in toxicities.

Full description

The specific aims of this study are:

1. To establish hypoxia imaging in NPC patients
2. Investigate the dynamics of tumor hypoxia before and during chemoradiation
3. Integrate hypoxia imaging into radiation treatment planning protocols
4. Design hypoxia adapted radiation schedules
5. Identify candidate hypoxia biomarkers

Enrollment: 9 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T3-T4 disease with no evidence of distant metastasis.
• Histological diagnosis of WHO Type II or III NPC
• No evidence of distant metastases in staging work up (including lung, liver and bone imaging).
• Planned for upfront radiotherapy and/or chemotherapy.
• Cross sectional imaging of the primary and neck disease (MRI preferred)
• Performance status of ECOG grade 0 or 1
• No prior tumour therapy
• At least 21 years of age, of either sex.
• Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential;
• Adequate bone marrow, renal and hepatic function defined as follows:

Bone marrow: WBC > 3000 / mm3 (ANC > 1500 / mm3 ) Platelets > 100 000 / mm3. Hb > 10 gm/dl Renal: serum creatinine within institutional normal range(or) lower than the lower limit of institutional normal range : calculated creatinine clearance > 50 ml / min Hepatic: enzymes (SAP, SGOT) < 2x normal: bilirubin < 24 mol / l.

Exclusion criteria

• Allergic to 18F-fluoromisonidazole or Nitroimidazoles
• Planned for neoadjuvant chemotherapy
• Uncontrolled hypercalcaemia: calcium 2.7 mmol/L (10.8 mg/dL).
• Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
• Have serious active infection.
• Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

PET/CT imaging

Experimental group

Description:

Intravenous injection of 370MBq ± 10% (18)F-fluoromisonidazole

Treatment:

Radiation: (18)F-fluoromisonidazole (FMISO)