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

This is an interventional diagnostic trial for Carcinoma, Non-Small-Cell Lung focused on measuring Carcinoma, non-small-cell lung, Head and neck neoplasms, Diagnostic imaging Read More

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.