Actively Recruiting
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Led by National Cancer Institute (NCI) · Updated on 2026-04-24
130
Participants Needed
1
Research Sites
794 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with surgically inoperable pheochromocytoma or paraganglioma confirmed by tissue diagnosis
- Disease progression within the last 12 months as shown by RECIST 1.1 criteria
- Positive somatostatin receptor status shown by Ga-68-DOTATATE PET scan within 12 weeks before treatment
- Measurable disease according to RECIST 1.1
- Karnofsky Performance Score of 60 or higher or ECOG Performance Status of 2 or better
- Able to understand and willing to sign informed consent
- Willing and able to complete all required scans during the study
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective non-hormonal contraception during and after the study period for specified durations
- Have an outside endocrinologist or medical oncologist to follow care after therapy
- Receiving adequate medication for secreting tumors
- Unable or unwilling to receive standard first-line therapy for pheochromocytoma/paraganglioma
You will not qualify if you...
- Creatinine clearance less than 50 mL/min
- Serum albumin 3.0 g/dL or less unless prothrombin time is normal
- Severe liver dysfunction (Child's Class C) or high liver enzyme levels unless liver metastases present
- Low blood counts: hemoglobin below 8.0 g/dL, white blood cells below 2.0 x 10^9/L, or platelets below 100 x 10^9/L
- Severe congestive heart failure (NYHA class III or IV)
- Pregnancy or breastfeeding
- Previous anti-tumor radionuclide therapy with unsealed sources
- Known brain metastases unless treated and stable for at least 24 weeks
- Other active cancers except certain skin or cervical cancers unless disease-free for 5 years
- Participation in another investigational therapy trial within the last 30 days
- Recent changes to somatostatin analogue therapy within 3 months before enrollment
- Patient weight exceeding scanner limits (about 400 lbs)
- Uncontrolled illness such as infection, heart problems, high blood pressure, arrhythmia, or psychiatric/social issues
- Unable to tolerate diagnostic imaging like CT or MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Joy H Zou, R.N.
CONTACT
F
Frank I Lin, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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