68Ga-DOTATATE Imaging for Neuroblastoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Etienne Rousseau, MD, FRCPC

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Disqualifiers: Other cancer, Randomized trial, Unstable, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Staging of the disease can be done by different imaging strategies (CT, MRI, scintigraphy and PET/CT). Discrepancies may be observed among these different strategies resulting in different treatment strategies. The goal of this study is to assess the feasibility and safety of 68Ga-DOTATATE and to compare it to 123I-MIBG when investigating neuroblastoma.

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

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should not be currently under treatment, which might imply stopping certain medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the drug 68Ga-DOTATATE for neuroblastoma?

68Ga-DOTATATE PET/CT scans have shown high accuracy and excellent spatial resolution in detecting neuroblastoma, making it a reliable alternative to traditional imaging methods like 123I-MIBG. It has been found to be more specific and sensitive than other imaging techniques, helping in better detection and assessment of the disease. ^{1 2 3 4 5}

Is 68Ga-DOTATATE safe for use in humans?

68Ga-DOTATATE is approved by the Food and Drug Administration for imaging certain types of tumors, indicating it has been evaluated for safety in humans. However, further studies are needed to confirm its safety for neuroblastoma specifically. ^{2 3 5 6 7}

How is the treatment 68Ga-DOTATATE different from other treatments for neuroblastoma?

68Ga-DOTATATE is unique because it is a PET imaging agent that targets somatostatin receptors, providing higher sensitivity and better spatial resolution than traditional imaging methods like 123I-MIBG. This makes it particularly useful for accurately staging and assessing the response to therapy in neuroblastoma, especially when other imaging agents are difficult to obtain. ^{2 3 4 5 7}

Research Team

Etienne Rousseau, MD, FRCPC

Principal Investigator

CIUSSSE-CHUS

Eligibility Criteria

This trial is for children and young adults up to 21 years old with new or recurring neuroblastoma. Participants must be able to give consent in French or English, have a planned 123I-MIBG imaging, and not currently be under treatment or part of another randomized control trial.

Inclusion Criteria

I have a new or returning neuroblastoma diagnosis.

I am scheduled for a special heart scan.

I am 21 years old or younger.

Exclusion Criteria

I have not had any cancer other than non-melanoma skin cancer in the last 5 years.

You are currently participating in a study where you do not know if you are receiving the new treatment or a placebo.

I have not had surgery or medical intervention on my tumor between two specific scans.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo a 68Ga-DOTATATE PET/CT scan and 123I-MIBG scintigraphy imaging

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

2 years

Treatment Details

Interventions

• 68Ga-DOTATATE (Radiopharmaceutical)

Trial Overview The study tests the safety and effectiveness of a radiopharmaceutical called 68Ga-DOTATATE in detecting neuroblastoma compared to the current standard, which uses 123I-MIBG imaging. It aims to see if this new method can provide clearer results.

Participant Groups

Group I: Single arm with 68Ga-DOTATATE Experimental Treatment 1 Intervention

all participants will undergo a PET scan with 68Ga-DOTATATE

Who Is Running the Clinical Trial?

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead Sponsor

Trials

64

Recruited

33,600+

Dr. André Carpentier

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Chief Executive Officer since 2020

MD, Université de Sherbrooke

Dr. Adam Frenette

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Chief Medical Officer since 2023

MD, Université de Sherbrooke

Findings from Research

(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 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]

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]

The optimized preparation of 68Ga-DOTATOC achieved a high radiochemical purity of over 98%, indicating its reliability for clinical use in PET imaging.

Dosimetric evaluations revealed that the pancreas, kidneys, and adrenal glands receive the highest absorbed doses from 68Ga-DOTATOC, with an effective dose of 0.026 mSv/MBq, suggesting it is a safe option for imaging somatostatin receptor-positive tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Study of 68Ga-DOTATOC: Biodistribution Assessment in Syrian Rats and Evaluation of Absorbed Dose in Human Organs. Naderi, M., Zolghadri, S., Yousefnia, H., et al.[2023]

In a study of 237 patients undergoing Ga-68 DOTATATE PET/CT for neuroendocrine tumors, 11% exhibited atypical thyroid uptake, indicating a notable occurrence that warrants further investigation.

Among patients with focal uptake, 71% had thyroid nodules, and 21% were diagnosed with papillary thyroid cancer, highlighting the importance of clinical evaluation for potential malignancies in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Rate and Clinical Significance of Incidental Thyroid Uptake as Detected by Gallium-68 DOTATATE Positron Emission Tomography/Computed Tomography. Nockel, P., Millo, C., Keutgen, X., et al.[2019]

References

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

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

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

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

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

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

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

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

6. Iran pubmed.ncbi.nlm.nih.gov

Preclinical Study of 68Ga-DOTATOC: Biodistribution Assessment in Syrian Rats and Evaluation of Absorbed Dose in Human Organs. [2023]

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

The Rate and Clinical Significance of Incidental Thyroid Uptake as Detected by Gallium-68 DOTATATE Positron Emission Tomography/Computed Tomography. [2019]