An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation

Inclusion Criteria

• 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: - Previously untreated, histologically or cytologically confirmed (from the primary tumor and/or lymph nodes) stage III-IV disease without evidence of distant metastases. - A measurable (i) primary tumor with at least one diameter ≥2 cm and (ii) lymph node with at least one diameter ≥ 2 cm as confirmed by a diagnostic quality neck 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. - Have undergone the following minimum workup to confirm disease staging within 4 weeks prior to initiation of the concurrent CRT: - Whole-body FDG PET/CT. - Patients ≥ 18 years of age. - Able to comply with lying still during the PET/CT imaging session which may last for up to 3 hrs with intermediate breaks. - ECOG performance status of 0, 1 or 2. - Adequate renal function and adequate hepatic function, as assessed by standard laboratory criteria and defined as: - Serum creatinine ≤ 1.2 times the Upper Limit of Normal (ULN). - Total bilirubin ≤ 1.5 times the ULN. - Asparagine aminotransferase (AST) and/or alanineaminotransferase (ALT) ≤ 2.5 times the ULN (grade 1 according to the NCI-CTCAE v.3). - Women of child-bearing potential must have a negative blood pregnancy test at screening and use an adequate and medically acceptable contraceptive method. - Willing and able to comply with the protocol requirements. - Able to provide written informed consent. 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. - Treatment with induction chemotherapy. - Any contraindication to CT with IV contrast agent. - Evidence of distant metastases. - Patients who, based on the investigator's judgment, have other unstable medical conditions that may preclude safe and complete study participation. - Treatment with any investigational drug, device or biologic agent within 30 days prior to administration of [18F]-ML-10. - Pregnancy or lactation.