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Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma

NCT03206060 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-04-24

No results posted yet for this study

Summary

Background:

Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help.

Objective:

To learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return.

Eligibility:

Adults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET/CT imaging

Design:

Participants will be screened with a medical history, physical exam, and blood tests.

Eligible participants will be admitted to the NIH Clinical Center.

Participants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart.

Between 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table.

Participants will have vital signs taken. They will give blood and urine samples.

During the study, participants will have other scans taken. Some scans will use a radioactive tracer.

Participants will complete quality of life questionnaires.

Participants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.

Conditions

Interventions

DRUG

Lu-177-DOTATATE

Lu-177-DOTATATE IV at weeks 1, 8, 16 and 24.

DRUG

Ga-68-DOTATATE

Ga-68-DOTATATE PET/CT at weeks 15 and 31, every 24 weeks during 3 years follow up period.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Frank I Lin, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2030-01-01
Completion
2033-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03206060 on ClinicalTrials.gov