68Ga-DOTATATE PET/CT Scan for Neuroblastoma

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new method to diagnose neuroendocrine tumors in children using a special scan called 68Ga-DOTATATE PET/CT. Neuroendocrine tumors are unusual growths that can mimic hormone-producing cells and sometimes spread. The trial aims to determine if this scan is more effective than the standard method for detecting these tumors and planning radiation treatments. Children and young adults under 30 with high-risk neuroblastoma (a type of neuroendocrine tumor) that has spread may qualify if they plan to undergo radiation therapy. Participants will receive a radioactive tracer and undergo a scan to help doctors develop the best treatment plan. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to benefit from this innovative diagnostic approach.

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 prior data suggests that this scan is safe for diagnosing pediatric neuroendocrine tumors?

Research has shown that 68Ga-DOTATATE PET/CT scans are generally safe. In previous studies, children and young adults with certain solid tumors handled this type of scan well. The radioactive substance used, 68Ga-DOTATATE, is considered safe for both adults and children with tumors that have specific proteins targeted by the tracer.

This scan identifies tumors by making them visible on images, which is crucial for accurate diagnosis. So far, no major safety issues have been reported, making it a promising diagnostic tool. However, as this is an early trial, further research is needed to fully understand its safety in this specific context. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 68Ga-DOTATATE PET/CT scan for neuroblastoma because it offers a more precise way to detect and plan treatment for high-risk neuroendocrine cancers. Unlike traditional imaging methods like MRI or standard CT scans, this approach uses the radioactive tracer Gallium Ga 68-DOTATATE, which targets specific receptors on tumor cells, providing clearer images and potentially earlier detection of cancerous activity. This precision could lead to more tailored and effective treatment plans, improving outcomes for patients.

What evidence suggests that the 68Ga-DOTATATE PET/CT scan is effective for diagnosing pediatric metastatic neuroendocrine tumors?

Research has shown that 68Ga-DOTATATE PET/CT scans are promising for diagnosing neuroendocrine tumors. Studies have demonstrated that this imaging method is highly accurate in detecting tumors that have spread, potentially surpassing other scans like the MIBG scan. One study found that all patients tested showed positive results with the 68Ga-DOTATATE scan, suggesting it could be very effective in identifying cancerous growths. In this trial, participants in both Cohort A and Cohort B will receive 68Ga-DOTATATE intravenously and undergo PET/CT scans. This scan helps doctors see the tumors more clearly and could improve treatment planning. Overall, evidence suggests that 68Ga-DOTATATE PET/CT is a strong tool for diagnosing and managing neuroendocrine tumors. ^{2 6 7 8 9}

Who Is on the Research Team?

Nadia Laack, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

(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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4138137/

The value of 68Ga-DOTATATE PET/CT in diagnosis and ... Ga-DOTATATE has also been proven to have high impact on management of the neuroendocrine cancer patients indicating an important role in clinical practice of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10174405/

Comparison of the application of 18F-FDG and 68Ga ... The present study aimed to compare the efficacy of 68 Ga-DOTATATE PET/CT and 18 F-FDG PET/CT imaging in the diagnosis, staging, and prognosis evaluation of ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/58/11/1718

Current Concepts in 68Ga-DOTATATE Imaging of ... This article provides a guide to the performance and interpretation of 68 Ga-DOTATATE PET/CT and describes its role in the diagnostic algorithm of ...

4. ajronline.org ajronline.org/doi/10.2214/AJR.18.19881

Neuroendocrine Tumor Diagnosis and Management Gallium-68 DOTATATE PET/CT has good diagnostic accuracy to detect distant metastases and can have significant impact on patient management (Fig. 3). The liver ...

5. researchgate.net researchgate.net/publication/350645699_68_Ga-DOTATATE_PETCT_for_Neuroblastoma_staging_Utility_for_clinical_use

68 Ga-DOTATATE PET/CT for Neuroblastoma staging. ... 68Ga DOTATATE PET/CT scans were successfully carried out in all patients. All patients showed DOTATATE avid disease. PET scans showed excellent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5698616/

Safety and accuracy of 68Ga-DOTATOC PET/CT in children ... 68 Ga-DOTATOC PET/CT is safe and accurate in children and young adults with solid tumors expressing somatostatin receptor type 2.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04040088

An Investigational Scan (68Ga-DOTATATE PET/CT) in ... This trial studies how well an investigational scan called 68Ga-DOTATATE PET/CT works in diagnosing pediatric patients with neuroendocrine tumors that have ...

8. novartis.com novartis.com/us-en/sites/novartis_us/files/netspot.pdf

NetSpot The safety profile of gallium Ga 68 dotatate is similar in adult and pediatric patients with somatostatin receptor positive tumors. The recommended gallium Ga ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/gallium-ga-68-dotatate-intravenous-route/description/drg-20312288

Gallium ga 68 dotatate (intravenous route) - Side effects & ... Gallium Ga 68 dotatate injection is used with a PET scan (positron emission tomography) for localization of somatostatin receptor positive neuroendocrine ...