Back to results18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study
Primary Purpose
Nasopharyngeal Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
(18)F-fluoromisonidazole (FMISO)
Sponsored by
About this trial
This is an interventional diagnostic trial for Nasopharyngeal Carcinoma focused on measuring Hypoxia, FMISO, PET, Nasopharyngeal cancer
Eligibility Criteria
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
Sites / Locations
- Singapore General Hospital
- National Cancer Centre, Singapore
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET/CT imaging
Arm Description
Intravenous injection of 370MBq ± 10% (18)F-fluoromisonidazole
Outcomes
Primary Outcome Measures
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.
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
To estimate the correlation between immunohistochemical expression of CA-IX, VEGF and HIF-1a, (marker of hypoxia) and pre-treatment PET-SUV measurement
To correlate 18F-FMISO PET uptake with tumor response at 3 months post radiotherapy, local control rate and disease free survival.
Secondary Outcome Measures
Full Information
NCT ID
NCT04995185
First Posted
July 29, 2021
Last Updated
August 9, 2021
Sponsor
National Cancer Centre, Singapore
Collaborators
Terry Fox Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04995185
Brief Title
18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study
Official Title
18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore
Collaborators
Terry Fox Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The specific aims of this study are:
To establish hypoxia imaging in NPC patients
Investigate the dynamics of tumor hypoxia before and during chemoradiation
Integrate hypoxia imaging into radiation treatment planning protocols
Design hypoxia adapted radiation schedules
Identify candidate hypoxia biomarkers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Hypoxia, FMISO, PET, Nasopharyngeal cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/CT imaging
Arm Type
Experimental
Arm Description
Intravenous injection of 370MBq ± 10% (18)F-fluoromisonidazole
Intervention Type
Radiation
Intervention Name(s)
(18)F-fluoromisonidazole (FMISO)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To investigate the dynamics of tumour hypoxia
Description
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.
Time Frame
From baseline and during 7 week long treatment regimen
Title
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.
Description
Number of patients with feasible radiotherapy plan dose-escalation to more than 84Gy
Time Frame
At baseline and week 3 of RT
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiattisa Sommat, MD
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
National Cancer Centre, Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
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18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study
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