NCT03923257 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bodei L, Cremonesi M, Ferrari M, Pacifici M, Grana CM, Bartolomei M, Baio SM, Sansovini M, Paganelli G
Long-term evaluation of renal toxicity after peptide receptor radionuclide therapy with 90Y-DOTATOC and 177Lu-DOTATATE: the role of associated risk factors. Eur J Nucl Med Mol Imaging. 2008 Oct;35(10):1847-56. doi: 10.1007/s00259-008-0778-1. Epub 2008 Apr 22. Erratum in: Eur J Nucl Med Mol Imaging. 2008 Oct;35(10):1928.
Madsen MT, Menda Y, O'Dorisio TM, O'Dorisio MS
Technical Note: Single time point dose estimate for exponential clearance. Med Phys. 2018 May;45(5):2318-2324. doi: 10.1002/mp.12886. Epub 2018 Apr 16.
Menda Y, Madsen MT, O'Dorisio TM, Sunderland JJ, Watkins GL, Dillon JS, Mott SL, Schultz MK, Zamba GKD, Bushnell DL, O'Dorisio MS
(90)Y-DOTATOC Dosimetry-Based Personalized Peptide Receptor Radionuclide Therapy. J Nucl Med. 2018 Nov;59(11):1692-1698. doi: 10.2967/jnumed.117.202903. Epub 2018 Mar 9.

Phase I Trial of Peptide Receptor Radiotherapy (PRRT) With 177Lu-DOTA-tyr3-Octreotate (177Lu-DOTATATE) in Children and Adolescents With Neuroendocrine Tumor or Pheochromocytoma/Paraganglioma

Details for clinical trial NCT03923257

Clinical trial NCT03923257 - References