Standardization of Dosimetry in 177Lu Targeted Radionuclide Therapy

Standardization of Dosimetry in 177Lu Targeted Radionuclide Therapy and Development of the Practical Manual - Standardization of Dosimetry in 177Lu Targeted Radionuclide Therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057478

Enrollment

Registered

2025-04-01

Start date

2024-05-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age: >19 years Laboratory Tests (within 1 month before treatment): eGFR >50 mL/min Hemoglobin >10 g/dL White blood cell count 3000-10000/microliter Platelet count >75000/microliter Albumin >3 g/dL Bilirubin <3 mg/dL Cognitive Function: Hasegawa Dementia Scale (HDS-R) score >20 Ability to take oral nutrition independently Ability to manage insulin therapy and medication independently Ability to manage urination (use of pads or other aids is acceptable if necessary) WHO Performance Status: 0-1

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded: 1) Presence of urgent findings on chest or abdominal CT. 2) History of hypersensitivity to Lu-DOTATE, L-lysine hydrochloride, or L-arginine hydrochloride. 3) Pregnant or breastfeeding women, or women with the potential for pregnancy who are not using appropriate contraception. 4) Men with a partner who has the potential for pregnancy and who are not using appropriate contraception. 5) Patients with endogenous psychiatric disorders, such as schizophrenia, or those with psychiatric symptoms that would make study participation difficult. 6) The presence of an active systemic infection requires treatment. 7) Inability to maintain a stable position for more than 30 minutes. 8) Any other medical, psychological, or other factors that the principal investigator deems inappropriate for participation.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is whether the renal dose error using the two-point method (simulation using 24,168 hours' data after 177Lu-DOTATATE injection) is acceptable (within the allowable error) compared to the four-point method using 4,24,96, and 168 hours' data after the injection.	—

Countries

Japan

Contacts

Public ContactTaro Murai

Shonan Kamakura General Hospital Department of Radiation Oncology

t_murai@shonankamakura.or.jp09033008419

Outcome results