Nasopharyngeal CarcinomaNCT04995185
18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study
A study testing (18)F-fluoromisonidazole (FMISO) in people with Nasopharyngeal Carcinoma, run by National Cancer Centre, Singapore at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- (18)F-fluoromisonidazole (FMISO)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesSingapore
- Study dates
- 20 Jun 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital
Singapore, 169608
National Cancer Centre, Singapore
Singapore, 169610
About this study
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.
Read the 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
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- (18)F-fluoromisonidazole (FMISO)
- Keywords
- Hypoxia, FMISO, PET, Nasopharyngeal cancer
- Medical subject headings
- Nasopharyngeal Carcinoma, Hypoxia, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(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.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT imaging | Experimental | Intravenous injection of 370MBq ± 10% (18)F-fluoromisonidazole Receives: Radiation: (18)F-fluoromisonidazole (FMISO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: At baseline
To correlate 18F-FMISO PET uptake with tumor response at 3 months post radiotherapy, local control rate and disease free survival.
Measured: From baseline up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start20 Jun 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Terry Fox Foundation
- Responsible party
- Sponsor
- Investigators
- Kiattisa Sommat, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995185
- Sponsor's protocol ID
- MISSION16
- Status last verified
- May 2024
- First submitted
- 29 Jul 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study
- ClinicalTrials.gov ID
- NCT04995185
- Acronym / sponsor ID
- MISSION16
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Hypoxia, FMISO, PET, Nasopharyngeal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Terry Fox Foundation
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT imaging | Experimental | Radiation: (18)F-fluoromisonidazole (FMISO)Intravenous injection of 370MBq ± 10% (18)F-fluoromisonidazole |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (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. | Radiation | PET/CT imaging |
Primary outcome
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.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiattisa Sommat, MD principal investigator
National Cancer Centre, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (18)F-fluoromisonidazole (FMISO) in people with Nasopharyngeal Carcinoma, run by National Cancer Centre, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the dynamics of tumour hypoxia (time frame: From baseline and during 7 week long treatment regimen). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.