NCT02123407 - 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)

Catarci M, Guadagni S, Zaraca F, Pistoia MA, Mastracchio A, Trecca A, Ruco L, Carboni M
Prospective randomized evaluation of preoperative endoscopic vital staining using CH-40 for lymph node dissection in gastric cancer. Ann Surg Oncol. 1998 Oct-Nov;5(7):580-4.
Okamoto K, Sawai K, Minato H, Yada H, Shirasu M, Sakakura C, Otsuji E, Kitamura K, Taniguchi H, Hagiwara A, Yamaguchi T, Takahashi T
Number and anatomical extent of lymph node metastases in gastric cancer: analysis using intra-lymph node injection of activated carbon particles (CH40). Jpn J Clin Oncol. 1999 Feb;29(2):74-7.
Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group
D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035.
Siewert JR, Kestlmeier R, Busch R, Böttcher K, Roder JD, Müller J, Fellbaum C, Höfler H
Benefits of D2 lymph node dissection for patients with gastric cancer and pN0 and pN1 lymph node metastases. Br J Surg. 1996 Aug;83(8):1144-7.

Clinical Study on the Harvesting Lymph Nodes With Carbon Nanoparticles for Advanced Gastric Cancer：a Prospective Randomized Study

Clinical trial NCT02123407 - References