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Clinical Trial 1

Protocol 20110059/Gulec002 GALLIUM-68 MACROAGGREGATED ALBUMIN (Ga-68 MAA) POSITRON EMISSION TOMOGRAPHY/COMPUTERIZED TOMOGRAPHY (PET/CT) IMAGING FOR EVALUATION OF HEPATIC ARTERIAL PERFUSION IN PATIENTS WITH PRIMARY AND METASTATIC LIVER CANCERS UNDERGOING Y-90 GLASS MICROSPHERE THERAPY

Category:
Phase I Diagnostic, Molecular Imaging

Protocol Synopsis:
The clinical study with the product is designed as a phase I study for determination of imaging characteristics of Ga-68 MAA, the stability of the radiolabel, and the safety of its administration in patients who are evaluated for Y-90 microsphere selective internal radiation treatment. The imaging characteristics Ga-68 MAA with the hepatic arterial administration including the distribution of the tracer in the tumor and liver compartments, lung fields as well as extra-hepatic gastrointestinal localization will be visually evaluated. The images will also be evaluated for presence (or absence) of free Ga-68 uptake, which would manifest as blood pool and diffuse tissue uptake.

Outcome Measures:
1. Imaging characteristics of Ga-68 MAA in patients with liver cancer
2. Correlation between Tc-99m MAA SPECT imaging and Ga-68 MAA PET/CT imaging.

Key Inclusion Criteria:

  • Patients with primary or metastatic liver cancer who are clinically determined to be candidates for Y90 microsphere RMT.
  • Age ≥ 18
  • Ability and willingness to give a written consent
  • Life expectancy > 3 months
  • ECOG Performance Status < 2
  • Adequate liver function. Bilirubin < 2 (without extrahepatic biliary obstruction), Albumin > 2, INR < 1.5 (without anticoagulation)
  • Adequate renal function. Creatinine < 2
  • Adequate bone marrow reserve. Platelets ≥ 100K, Hb ≥ 9, WBC ≥ 1.5K

Key Exclusion Criteria:

  • Age < 18
  • Pregnant and nursing women
  • Inability or unwillingness to give a written consent
  • Life expectancy < 3 months
  • ECOG Performance Status > 2
  • Liver dysfunction. Bilirubin > 2 (without extrahepatic biliary obstruction), Albumin < 2, INR > 1.5 (without anticoagulation)
  • Renal dysfunction. Creatinine > 2
  • Inadequate bone marrow reserve. Platelets <1 00K, Hb < 9, WBC < 1.5K
  • Allergy to albumin products or Gallium
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Clinical Trial 2

Protocol 20111993/Gulec003 [I-124] NaI POSITRON EMISSION TOMOGRAPHY/COMPUTERIZED TOMOGRAPHY (PET/CT) IMAGING AND DOSIMETRY IN PATIENTS WITH DIFFERENTIATED THYROID CANCER

Category:
Phase I Diagnostic, Molecular Imaging

Protocol Synopsis:
I-124 NaI metabolism and thyroid cancer imaging capability in humans has been studied, and its safety as an imaging agent has been demonstrated in a number of early studies. Our study is planned to investigate the diagnostic efficacy and develop a protocol for dosimetry in preparation to radioactive iodine treatment with I-131.

Outcome Measures:
1. Imaging characteristics of I-124 NaI in patients with differentiated thyroid cancer
2. Correlation between the diagnostic 2mCi -124 and post-treatment I-131 images

Key Inclusion Criteria:

  • Patients with clinically diagnosed differentiated thyroid cancer with known or suspected recurrence or metastases
  • Age ≥ 18
  • Ability and willingness to give a written consent
  • Life expectancy > 3 months
  • Karnofsky performance status ≥ 70

Key Exclusion Criteria:

  • Age < 18
  • Inability or unwillingness to give a written consent
  • Life expectancy < 3 months
  • Karnofsky performance status < 70
  • Pregnant and nursing women. A urine pregnancy test will be performed prior to the investigational radiotracer injection.
  • Individuals allergic to iodine
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