68Ga-DOTATATE PET/CT Scan for Neuroblastoma
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byNadia Laack
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Waitlist Available
Sponsor: Mayo Clinic
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial studies how well an investigational scan called 68Ga-DOTATATE PET/CT works in diagnosing pediatric patients with neuroendocrine tumors that have spread to other places in the body (metastatic). A neuroendocrine tumor is an abnormal growth of neuroendocrine cells, which are cells resembling nerve cells and hormone-producing cells. 68Ga-DOTATATE is a radioactive substance called a radiotracer that when used with PET/CT scans, may work better than standard of care MIBG scans in diagnosing pediatric metastatic neuroendocrine tumors and targeting them with radiation therapy.
Do I need to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are immunocompromised or on antiretroviral therapy, you may not be eligible to participate.
What data supports the idea that 68Ga-DOTATATE PET/CT Scan for Neuroblastoma is an effective treatment?
The available research shows that 68Ga-DOTATATE PET/CT scans are effective for neuroblastoma because they can accurately identify tumor locations and changes over time. They are more specific and sensitive than other imaging methods like 123I-MIBG and MRI. This means they can detect tumors earlier and more clearly, which helps doctors assess how well the treatment is working. Additionally, during the COVID-19 pandemic, 68Ga-DOTATATE was used as an alternative to 123I-MIBG due to supply issues, and it showed high accuracy and excellent image quality. Overall, 68Ga-DOTATATE PET/CT scans offer practical and technical advantages, making them a reliable option for managing neuroblastoma.
12345What safety data exists for 68Ga-DOTATATE PET/CT in neuroblastoma treatment?
68Ga-DOTATATE PET/CT is FDA-approved for imaging somatostatin receptor-positive tumors and has been used in neuroblastoma staging and response evaluation. Studies show it has high accuracy, better spatial resolution, and is more sensitive and specific than traditional imaging methods like 123I-MIBG and MRI. It is effective in detecting early progression and assessing bone and bone marrow disease. However, further multicenter studies are needed to establish its safety and efficacy for standard clinical use in neuroblastoma.
12346Eligibility Criteria
This trial is for children and young adults up to age 30 with certain types of neuroendocrine tumors, including neuroblastoma, that have spread. They must be fit enough for radiation therapy and not pregnant or breastfeeding unless they agree to use birth control. Participants need to consent and commit to follow-up at the enrolling institution.Inclusion Criteria
I am scheduled for radiation therapy at the institution where I am enrolling.
My neuroblastoma is high-risk and needs additional radiation therapy.
Signed written informed consent from patient, parent, and/or legal guardian
+5 more
Exclusion Criteria
Pregnant women, nursing women who refuse to stop breastfeeding, or men/women of childbearing age who are unwilling to use an effective birth control method
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
I am HIV positive but not immunocompromised, or I am on antiretroviral therapy.
Participant Groups
The study tests a new scan called 68Ga-DOTATATE PET/CT in kids with metastatic neuroendocrine tumors. It checks if this radioactive tracer scan is better than current MIBG scans for diagnosis and helps target radiation treatment more effectively.
2Treatment groups
Experimental Treatment
Group I: Cohort B (68Ga-DOTATATE, PET/CT)Experimental Treatment3 Interventions
Patients with previously diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE IV and undergo PET/CT over 20-30 minutes at the time of radiation treatment planning.
Group II: Cohort A (68Ga-DOTATATE, PET/CT)Experimental Treatment3 Interventions
Patients with newly diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE intravenously (IV) and undergo PET/CT over 20-30 minutes at diagnosis (before any treatment) and at the time of radiation treatment planning.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
68Ga-DOTATATE PET in Restaging and Response to Therapy in Neuroblastoma: A Case Series and a Mini Review. [2023]68Ga-DOTATATE PET/CT is widely used for the evaluation of neuroendocrine tumors. Some reports exist on its use in the management of neuroblastoma. Building on the prior reports as well as our previous experience in using this technique for initial staging, we propose to describe its practical benefits in restaging and response to therapy. We describe different aspects including supply logistics, preparation, spatial resolution, and other practical applications. Methods: We reviewed the medical records for 8 patients who were evaluated with 68Ga-DOTATATE PET/CT at our institution over 2 y. A note was made of the patient and disease characteristics and the indication for PET imaging, and the results were retrospectively analyzed for feasibility, logistics, radiation exposure, and utility in answering the clinical question. Results: Eight children (5 girls and 3 boys; age range, 4-60 mo; median age, 30 mo) diagnosed with neuroblastoma were imaged with 68Ga-DOTATATE PET/CT and 5 with 123I-metaiodobenzylguanidine (123I-MIBG) SPECT/CT over 2 y. Three 68Ga-DOTATATE PET scans were done for staging, 10 for response evaluation, and 2 for restaging. 68Ga-DOTATATE PET accurately identified neuroblastoma lesions suspected or seen on anatomic imaging. It has been shown to be more specific and more sensitive than 123I-MIBG and at times also MRI. It had better spatial and contrast resolution than 123I-MIBG. 68Ga-DOTATATE PET was better than 123I-MIBG SPECT/CT, CT, and MRI in the detection of early progression and viable tumor delineation for response assessment, as well as in target volume definition for external-beam radiotherapy and proton-beam radiotherapy. 68Ga-DOTATATE PET was also better at assessing bony and bone marrow disease changes with time. Conclusion: 68Ga-DOTATATE PET/CT offers added value and a superior edge to other imaging modalities in restaging and response assessment in neuroblastoma patients. Further multicenter evaluations in larger cohorts are needed.
68Ga-DOTATATE PET/CT for Neuroblastoma Staging: Utility for Clinical Use. [2021]Metaiodobenzylguanidine (MIBG) imaging has been the standard for neuroblastoma staging for many decades. Novel agents such as 18F-DOPA and 68Ga-DOTATATE are being used nowadays in academic centers. During the coronavirus disease 2019 (COVID-19) pandemic, procurement of 123I-MIBG has proved particularly challenging, necessitating the use of 68Ga-DOTATATE PET. 68Ga-DOTATATE is Food and Drug Administration-approved for imaging of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. Methods: 68Ga-DOTATATE PET/CT imaging was performed for staging of 3 pediatric patients with neuroblastoma at our institution. A review of the literature was also completed. Results: 68Ga-DOTATATE PET/CT scans were successfully performed on all patients. All patients showed 68Ga-DOTATATE-avid disease. PET scans showed an excellent spatial resolution and demonstrated high accuracy in concordance with current European Association of Nuclear Medicine guidelines. Conclusion: We have presented 68Ga-DOTATATE PET/CT imaging for staging of neuroblastoma and believe it can reliably be used as an alternative to 123I-MIBG. It has technical, clinical, and practical advantages making it an attractive option. Further multicenter studies are required before it can be recommended for standard clinical use.
Ga-68 DOTATATE positron emission tomography/computer tomography in initial staging and therapy response evaluation in a rare case of primary neuroblastoma in neck. [2021]Gallium-68 (Ga-68) DOTA-peptide positron emission tomography/computer tomography (PET/CT) has higher sensitivity and improved spatial resolution for the detection of somatostatin receptor expressing tumors than conventional somatostatin receptor scintigraphy. We present the findings of Ga-68 DOTATATE PET/CT in a rare case of primary neuroblastoma of the neck in a 12-year-old female child and its role in the evaluation of the treatment response.
177Lu-DOTATATE molecular radiotherapy for childhood neuroblastoma. [2019]This study tested the principle that (68)Ga-DOTATATE PET/CT may be used to select children with primary refractory or relapsed high-risk neuroblastoma for treatment with (177)Lu-DOTATATE and evaluated whether this is a viable therapeutic option for those children.
Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. [2019]Label="OBJECTIVE" NlmCategory="OBJECTIVE">In this study we aimed to present our experience on the use of Gallium-68-dotatate with positron emission tomography, computed tomography (68 Ga-dotatate PET/CT) in the management of neuroendocrine tumors (NET) and other somatostatin expressing tumors.
The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. [2021]Label="BACKGROUND"> 68 Gallium-DOTATATE (68 Ga-DOTATATE) is a somatostatin analog used as a PET tracer to successfully identify neuroendocrine tumors (NETs). Due to the rarity of sinonasal NETs, there are few recommendations for 68 Ga-DOTATATE imaging in these patients.