68Ga-DOTATATE PET/CT Scan for Neuroblastoma

Recruiting at 1 trial location

Overseen By Clinical Trials Referral Office

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Must not be taking: Antiretrovirals

Disqualifiers: Pregnancy, Immunocompromised, Severe disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

Trial Summary

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment 68Ga-DOTATATE PET/CT Scan for Neuroblastoma?

68Ga-DOTATATE PET/CT scans have shown to be more specific and sensitive than other imaging methods like 123I-MIBG and MRI for detecting neuroblastoma lesions, assessing treatment response, and identifying early disease progression. It offers better spatial and contrast resolution, making it a valuable tool for staging and restaging neuroblastoma. ^{1 2 3 4 5}

What 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. ^{1 2 3 4 6}

Is 68Ga-DOTATATE PET/CT safe for use in humans?

68Ga-DOTATATE PET/CT is generally considered safe for use in humans, as it is FDA-approved for imaging certain types of tumors and has been successfully used in children with neuroblastoma without reported safety issues in the studies reviewed. ^{1 2 3 4 6}

Is 68Ga-DOTATATE PET/CT a promising treatment for neuroblastoma?

Yes, 68Ga-DOTATATE PET/CT is a promising treatment for neuroblastoma. It offers better accuracy and detail in imaging compared to traditional methods, helping doctors to better understand and treat the disease. ^{1 2 3 4 6}

How does the 68Ga-DOTATATE PET/CT treatment differ from other treatments for neuroblastoma?

68Ga-DOTATATE PET/CT is unique because it provides more accurate and detailed imaging for neuroblastoma compared to traditional methods like 123I-MIBG. It offers better spatial and contrast resolution, making it superior in detecting early disease progression and assessing treatment response. ^{1 2 3 4 6}

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.

Research Team

Nadia Laack, MD

Principal Investigator

Mayo Clinic

Eligibility 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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnosis and Initial PET/CT

Patients receive 68Ga-DOTATATE IV and undergo PET/CT over 20-30 minutes at diagnosis

1 day

1 visit (in-person)

Radiation Treatment Planning

Patients undergo PET/CT over 20-30 minutes at the time of radiation treatment planning

Up to 3 months

1 visit (in-person)

Follow-up

Participants are monitored for patterns of failure after RT and associated outcomes

Up to 2 years

Treatment Details

Interventions

• Computed Tomography
• Gallium Ga 68-DOTATATE
• Positron Emission Tomography

Trial Overview 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.

Participant Groups

Group I: Cohort B (68Ga-DOTATATE, PET/CT) Experimental Treatment 3 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 Treatment 3 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

68Ga-DOTATATE PET/CT imaging was successfully used for staging neuroblastoma in three pediatric patients, showing high accuracy and excellent spatial resolution, making it a promising alternative to the traditional 123I-MIBG imaging.

The study suggests that 68Ga-DOTATATE PET/CT has technical and clinical advantages over 123I-MIBG, but further multicenter studies are needed before it can be widely recommended for standard clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-DOTATATE PET/CT for Neuroblastoma Staging: Utility for Clinical Use. Maaz, AUR., O'Doherty, J., Djekidel, M.[2021]

68Ga-DOTATATE PET/CT is more sensitive and specific than traditional imaging methods like 123I-MIBG SPECT/CT and MRI for detecting neuroblastoma lesions, making it a valuable tool for restaging and evaluating treatment response in children with neuroblastoma.

In a study of 8 pediatric patients, 68Ga-DOTATATE PET/CT demonstrated superior spatial and contrast resolution, effectively identifying viable tumor areas and changes in bone and bone marrow disease over time, suggesting its potential for improved clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-DOTATATE PET in Restaging and Response to Therapy in Neuroblastoma: A Case Series and a Mini Review. AlSadi, R., Maaz, AUR., Bouhali, O., et al.[2023]

Gallium-68 DOTA-peptide PET/CT is more sensitive and provides better spatial resolution for detecting tumors that express somatostatin receptors compared to traditional scintigraphy methods.

In a case study of a 12-year-old girl with primary neuroblastoma in the neck, Ga-68 DOTATATE PET/CT was effective in evaluating the tumor and assessing the response to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ga-68 DOTATATE positron emission tomography/computer tomography in initial staging and therapy response evaluation in a rare case of primary neuroblastoma in neck. Agrawal, K., Kumar, R., Shukla, J., et al.[2021]

(68)Ga-DOTATATE PET/CT imaging can effectively identify children with relapsed or refractory high-risk neuroblastoma who are eligible for treatment with (177)Lu-DOTATATE, as 6 out of 8 children showed sufficient uptake for therapy.

Treatment with (177)Lu-DOTATATE was found to be safe and feasible, with 5 out of 6 treated children achieving stable disease, and no significant renal toxicity reported, although some experienced grade 3 or 4 thrombocytopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

177Lu-DOTATATE molecular radiotherapy for childhood neuroblastoma. Gains, JE., Bomanji, JB., Fersht, NL., et al.[2019]

Gallium-68-dotatate PET/CT imaging demonstrated high sensitivity (94.16%) and specificity (91.89%) in detecting neuroendocrine tumors (NET) and other somatostatin expressing tumors, outperforming traditional CT scans.

In a study of 203 patients, PET/CT identified disease in 19 cases where CT was falsely negative, highlighting its superior ability to detect primary tumor sites and inform patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. Lawal, IO., Ololade, KO., Lengana, T., et al.[2019]

68 Ga-DOTATATE PET/CT imaging proved effective in identifying previously unknown primary tumors and metastatic disease in sinonasal neuroendocrine tumors, highlighting its potential for better diagnosis compared to conventional imaging methods.

In two cases of esthesioneuroblastoma, 68 Ga-DOTATATE detected abnormal uptake that was not visible on 18F-FDG PET/CT, suggesting it may be crucial for treatment planning, including identifying candidates for targeted therapies like 177 Lu-DOTATATE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. Liu, KY., Goldrich, DY., Ninan, SJ., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

68Ga-DOTATATE PET/CT for Neuroblastoma Staging: Utility for Clinical Use. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

68Ga-DOTATATE PET in Restaging and Response to Therapy in Neuroblastoma: A Case Series and a Mini Review. [2023]

3. India pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

177Lu-DOTATATE molecular radiotherapy for childhood neuroblastoma. [2019]

5. Greece pubmed.ncbi.nlm.nih.gov

Gallium-68-dotatate PET/CT is better than CT in the management of somatostatin expressing tumors: First experience in Africa. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The value of 68 Gallium-DOTATATE PET/CT in sinonasal neuroendocrine tumor management: A case series. [2021]