NCT01260480
Unknown
Phase 2
A Prospective, Multicenter Study, to Evaluate the Efficacy and Safety of [18F]-ML-10, a Positron Emission Tomography (PET) Imaging Radiotracer, in Early Detection of Response of Non-Hematological Tumors to Concurrent Chemoradiotherapy
Overview
- Phase
- Phase 2
- Sponsor
- Aposense Ltd.
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- To characterize changes in [18F]-ML-10 uptake in the target lesion in response to chemoradiotherapy.
Overview
Brief Summary
The purpose of this study is to determine whether [18F]-ML-10 used in conjunction with PET imaging is effective as an imaging tool for the early detection of response of oncological tumors in the lungs,head and neck to chemoradiation therapy.
The study will evaluate the potential of [18F]-ML-10 used in conjunction with PET imaging to distinguish early during the course of chemoradiation therapy between a tumor that responds to the therapy, and a tumor that does not respond to the therapy. Currently, this distinction is available to the physician several weeks or months after completion of therapy, using anatomical imaging (for example Computed Tomography [CT] or Magnetic Resonance Imaging [MRI]).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients with either:
- •Newly diagnosed non small cell lung cancer (NSCLC) (Group A) who meet the following criteria:
- •Previously untreated, histologically or cytologically confirmed stage IIB, IIIA or IIIB disease, without evidence of distant metastases
- •A measurable primary tumor with at least one diameter \> 2 cm or primary tumor extending to one or more lymph nodes which cannot be distinctively delineated as confirmed by a diagnostic quality chest CT performed within 4 weeks prior to initiation of the concurrent CRT.
- •Planned to receive concurrent chemoradiotherapy as definitive treatment. The radiation dose should not exceed 70 Gy.
- •Undergone the following minimum workup to confirm disease staging within 4 weeks prior to initiation of the concurrent CRT:
- •GBCA-enhanced Brain MRI or contrast enhanced CT if there are signs or symptoms suggesting brain metastases within the past 2 months.
- •If necessary to confirm stage of disease, an upper abdomen CT scan will be performed.
- •whole-body FDG PET/CT; OR
- •Newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) (Group B) who meet the following criteria:
Exclusion Criteria
- •Exclusion criteria specific to patients with NSCLC (Group A):
- •Predominant small cell carcinoma histology.
- •Pure bronchioalveolar cell carcinoma histology.
- •Treatment planned with chemotherapy other than a platinum-based doublet regimen.
- •Malignant pleural or pericardial effusions.
- •Any contraindication to perform CT with IV contrast agent.
- •Exclusion criteria specific to patients with SCCHN (Group B):
- •Histology other than squamous cell carcinoma.
- •Treatment planned with chemotherapy other than a platinum-based regimen.
- •Treatment planned with cetuximab.
Outcomes
Primary Outcomes
To characterize changes in [18F]-ML-10 uptake in the target lesion in response to chemoradiotherapy.
Time Frame: Between baseline and day 11 ± 1, and between baseline and day 18 ± 1
Secondary Outcomes
- To assess the correlation between the changes in the uptake of [18F]-ML-10 in the target lesion and the changes in the anatomical dimensions of the target lesion.
- To perform additional analyses for all other lesions and lymph nodes with at least one diameter ≥ 2 cm treated by concurrent CRT.
- To assess the safety of [18F]-ML-10 administered to cancer patients receiving concurrent CRT.
- To identify at least one parameter, derived from the changes in [18F]-ML-10 uptake that can discriminate tumors responsive to treatment from tumors that are non-responsive.
Investigators
Study Sites (4)
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