Clinical trial NCT04995185: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: Hypoxia
FMISO
PET
Nasopharyngeal cancer
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Terry Fox Foundation
First posted: 2021-08-06
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

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

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

Primary outcomes:
measure: To investigate the dynamics of tumour hypoxia
timeFrame: From baseline and during 7 week long treatment regimen
measure: 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.
timeFrame: At baseline and week 3 of RT
measure: To estimate the correlation between immunohistochemical expression of CA-IX, VEGF and HIF-1a, (marker of hypoxia) and pre-treatment PET-SUV measurement
timeFrame: At baseline
measure: To correlate 18F-FMISO PET uptake with tumor response at 3 months post radiotherapy, local control rate and disease free survival.
timeFrame: From baseline up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre, Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Kiattisa Sommat, MD
role: PRINCIPAL_INVESTIGATOR
References: