External radiation exposure to the families living with patients with neuroendocrine tumors receiving 177Lu-DOTATATE radiotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030240546

Enrollment

Registered

2024-12-12

Start date

2024-12-18

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

External radiation exposure

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients: 1) Patients with NET receiving 177Lu-DOTATATE therapy at standard dose (7.4 GBq+-10%). 2) Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3) Patients must be living with one or more people (e.g., spouse, partner, child, flat mate etc.) 4) Patients must give written informed consent form to allow them and their family members to participate in the study. 5) Patients must be 18 years of age or older. Inclusion criteria for study participants (family members): 1) Family members must provide written informed consent form to participate in the study. 2) Family members must be living with a patient undergoing 177Lu-DOTATATE radiation therapy. 3) Family members must be 18 years of age or older. 4) Family members should have normal cognitive function.

Exclusion criteria

Exclusion criteria: 1) Any patient/family member participating in another clinical trial or study. 2) Any patient/family member who is pregnant or lactating. 3) Any family member undergoing any radiotherapy or exposure to medical diagnostics. 4) Any family member who works in a radiation-related field (e.g.: HCPs, employees in radio pharma companies, etc.).

Design outcomes

Primary

Measure	Time frame
To evaluate the cumulative external exposure dose of family members living with patients treated with 177Lu-DOTATATE radiotherapy for 14 days.	—

Secondary

Measure	Time frame
-To evaluate the cumulative external exposure dose of the person accompanying the patient treated with 177Lu-DOTATATE radiotherapy, from hospital to home, on Day 1. -To evaluate the daily compliance of the study participant while he/she comes in close contact (less than 1 m distance) with the patient treated with 177Lu-DOTATATE radiotherapy. -To measure the 177Lu-DOTATATE residual radio activity.	—

Contacts

Public ContactKimiteru Ito

National Cancer Center Hospital

kimito@ncc.go.jp+81-3-3542-2511

Outcome results