Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Aposense Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
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.
Clareo Health | An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation
