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

August 9, 2021 updated by: National Cancer Centre, Singapore
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 169610
        • National Cancer Centre, Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PET/CT imaging
Intravenous injection of 370MBq ± 10% (18)F-fluoromisonidazole
Radiation: (18)F-fluoromisonidazole (FMISO)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate the dynamics of tumour hypoxia
Time Frame: From baseline and during 7 week long treatment regimen
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.
Time Frame: At baseline and week 3 of RT
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
Time Frame: At baseline
At baseline
To correlate 18F-FMISO PET uptake with tumor response at 3 months post radiotherapy, local control rate and disease free survival.
Time Frame: From baseline up to 5 years
From baseline up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

Terry Fox Foundation

Investigators

  • Principal Investigator: Kiattisa Sommat, MD, National Cancer Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2017

Primary Completion (ACTUAL)

December 30, 2020

Study Completion (ACTUAL)

December 30, 2020

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (ACTUAL)

August 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISSION16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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