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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995185
• Other study ID #: MISSION16
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2021
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Singapore	National Cancer Centre, Singapore	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	Terry Fox Foundation

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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