The efficacy of (177)Lu-labelled peptide receptor radionuclide therapy in patients with neuroendocrine tumours: a meta-analysis.
Seong-Jang Kim, Kyoungjune Pak, Phillip J Koo...
https://pubmed.ncbi.nlm.nih.gov/26253273Actively Recruiting
Phase 2
Age: 18Years - 100Years
All Genders
ID03206060
Lu-177-DOTATATE (Lutathera) Therapy for Inoperable Pheochromocytoma and Paraganglioma
Led by National Cancer Institute (NCI) · Updated on 2026-04-24
130
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pheochromocytoma and paraganglioma are rare tumors that develop from neural crest tissue, often found near the adrenal gland or in the neck. While surgery can effectively treat some tumors, many are inoperable or have spread, leaving limited treatment options. Researchers are studying Lu-177-DOTATATE, a drug that targets somatostatin receptors found on these tumors, to assess its safety and whether it can improve the time patients live without cancer progression. The study is a phase 2, open-label trial where participants receive Lu-177-DOTATATE through an intravenous infusion every 8 weeks for a total of four doses. Alongside the drug, participants receive an infusion of amino acids to protect the kidneys. Imaging scans, including PET/CT and MRI, are performed after the second and fourth doses to monitor treatment effects. The study includes two groups: those with a specific genetic mutation (SDHx) and those without known mutations. Participants will be evaluated with medical history, physical exams, blood and urine tests, and quality of life questionnaires. Scans using radioactive tracers will be done to track tumor response. After treatment, participants will be followed by phone and in-person visits every 3 to 6 months for up to three years, with yearly contacts thereafter to monitor survival and disease status. Researchers will measure progression-free survival at 6 months and other outcomes like tumor progression, safety, quality of life, biochemical markers, and medication use.
CONDITIONS
Brief Title
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Surgically inoperable pheochromocytoma or paraganglioma confirmed by pathology
- Progressive disease by RECIST 1.1 within the last 12 months
- Somatostatin receptor positive disease confirmed by Ga-68-DOTATATE PET scan within 12 weeks
- Measurable disease by RECIST 1.1
- Karnofsky Performance Score ≥ 60 or ECOG Performance Status ≤ 2
- Able to understand and willing to sign informed consent
- Ability to obtain all required scans per study schedule
- Negative pregnancy test for women of child-bearing potential
- Agreement to use effective non-hormonal contraception during and after study
- Have an outside endocrinologist or medical oncologist for follow-up
- If tumor is secreting, receiving adequate catecholamine blockade
- Unable or unwilling to receive standard first line therapy for pheochromocytoma/paraganglioma
You will not qualify if you...
- Creatinine clearance below 50 mL/min
- Serum albumin ≤ 3.0 g/dL unless prothrombin time normal
- Severe liver dysfunction or elevated liver enzymes beyond specified limits
- Low blood counts: hemoglobin < 8.0 g/dL, WBC < 2.0 x 10^9/L, platelets < 100 x 10^9/L
- Congestive heart failure NYHA class III or IV
- Pregnancy or lactation
- Prior anti-tumoral radionuclide therapy with unsealed sources
- Known brain metastases unless treated and stable for at least 24 weeks
- Other active malignancies except certain treated skin or cervical cancers
- Participation in other therapeutic clinical trials within 30 days
- Recent changes to somatostatin analogue therapy or inability to hold doses as required
- Weight over 400 lbs or exceeding PET scanner limits
- Uncontrolled illness or psychiatric/social issues limiting compliance
- Inability to tolerate diagnostic imaging such as CT or MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Approximately 24 weeks
Participants receive Lu-177-DOTATATE intravenously every 8 (+/- 2) weeks for a total of 4 administrations along with an amino acid infusion for kidney protection. Imaging studies including Ga-68-DOTATATE PET, F-18-FDG PET, and CT/MRI scans are performed after the 2nd and 4th administrations to monitor the disease.
4 treatment visits plus imaging after 2nd and 4th treatments; weekly contact and in-person visits every 4 weeks during treatment
Follow-up
Duration - Up to 3 years post-treatment with yearly contacts thereafter
After treatment ends, participants are followed every 12 weeks for up to 3 years with possible remote or telemedicine visits to assess disease status and survival. Yearly contacts continue after 3 years until death to monitor long-term outcomes.
Quarterly visits for 3 years, then yearly contacts
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
J
Joy H Zou, R.N.
F
Frank I Lin, M.D.
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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Published Research Related To This Trial
Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline.
Jacques W M Lenders, Quan-Yang Duh, Graeme Eisenhofer...
https://pubmed.ncbi.nlm.nih.gov/24893135A comparison of the performance of ⁶⁸Ga-DOTATATE PET/CT and ¹²³I-MIBG SPECT in the diagnosis and follow-up of phaeochromocytoma and paraganglioma.
J B Maurice, R Troke, Z Win...
https://pubmed.ncbi.nlm.nih.gov/22526961An automated pheochromocytoma and paraganglioma lesion segmentation AI-model at whole-body 68Ga- DOTATATE PET/CT.
Fahmida Haque, Jorge A Carrasquillo, Evrim B Turkbey...
https://pubmed.ncbi.nlm.nih.gov/39500789Early short-term effects on catecholamine levels and pituitary function in patients with pheochromocytoma or paraganglioma treated with [177Lu]Lu-DOTA-TATE therapy.
Sriram Gubbi, Mohammad Al-Jundi, Sungyoung Auh...
https://pubmed.ncbi.nlm.nih.gov/37886645Case Report: Primary Hypothyroidism Associated With Lutetium 177-DOTATATE Therapy for Metastatic Paraganglioma.
Sriram Gubbi, Mohammad Al-Jundi, Jaydira Del Rivero...
https://pubmed.ncbi.nlm.nih.gov/33551992