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

NCT04995185 | Completed

• 1 other identifier: MISSION16
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Hypoxia; FMISO; PET; Nasopharyngeal cancer

Outcome Measures

Primary Outcomes (4)

• To investigate the dynamics of tumour hypoxia

  A repeat 18F-FMISO-PET in week 3 of the 7 weeks long treatment regimen is planned. Fractionated radiotherapy is expected to induce reoxygenation within the tumor as iterative process by killing well oxygenated tumor cells with every fraction thereby reducing oxygen demand in the remaining tumor cells. Repetitive hypoxia imaging at week 3 allows for assessment of evolution of hypoxia during radiotherapy.

  From baseline and during 7 week long treatment regimen

• To evaluate proportion of patients with contour-able hypoxic volume as well as the feasibility of generating dose-escalation radiotherapy plan with dosimetrically achieved parameters for target volume and organs-at-risk.

  Number of patients with feasible radiotherapy plan dose-escalation to more than 84Gy

  At baseline and week 3 of RT

• To estimate the correlation between immunohistochemical expression of CA-IX, VEGF and HIF-1a, (marker of hypoxia) and pre-treatment PET-SUV measurement

  At baseline

• To correlate 18F-FMISO PET uptake with tumor response at 3 months post radiotherapy, local control rate and disease free survival.

  From baseline up to 5 years

Study Arms (1)

PET/CT imaging

EXPERIMENTAL

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

Radiation: (18)F-fluoromisonidazole (FMISO)

Interventions

(18)F-fluoromisonidazole (FMISO) RADIATION

Patients do not need to be fasted prior to intravenous injection of 370MBq ± 10% (18)F-fluoromisonidazole. Scanning will be performed two hours after the injection. Patients will be scanned with their thermoplastic shell used in routine radiotherapy treatment for 10 minutes, followed by approximately 5 minutes scan of the upper chest.

PET/CT imaging

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Terry Fox Foundation: collaborator

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

Location

National Cancer Centre, Singapore

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Hypoxia; Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kiattisa Sommat, MD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: June 20, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)