68Ga-DOTATATE Imaging for Neuroblastoma

Recruiting at 3 trial locations

Overseen By Marie-Pier Houde, MSc

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Disqualifiers: Other cancer, Randomized trial, Unstable, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method, 68Ga-DOTATATE (a radiotracer used in PET scans), for detecting neuroblastoma, a common childhood tumor. Researchers aim to determine if this method is safe and effective compared to the usual 123I-MIBG imaging. The process involves a PET scan, which helps doctors observe tumor behavior. Children or young adults with suspected or confirmed neuroblastoma who are scheduled for 123I-MIBG imaging are suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that 68Ga-DOTATATE is likely to be safe for humans?

Research has shown that 68Ga-DOTATATE is generally safe for use in medical imaging. Studies have found it rarely causes side effects requiring medical attention, indicating most people tolerate it well. In one study, 68Ga-DOTATATE altered treatment plans for 36% of participants without causing major side effects, demonstrating its effectiveness and safety for scans.

When used in PET scans (a type of imaging test that helps doctors see how tissues and organs are functioning), 68Ga-DOTATATE effectively identifies areas of disease, especially in challenging cases. Its use in other conditions further supports its safety. Overall, 68Ga-DOTATATE appears to be a safe option for imaging in individuals with neuroblastoma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for neuroblastoma?

Unlike the standard imaging methods for neuroblastoma, which often rely on MIBG scans, 68Ga-DOTATATE offers a unique approach by using a radiotracer that targets somatostatin receptors. This allows for potentially more precise detection of neuroblastoma tumors. Researchers are excited about 68Ga-DOTATATE because it could improve imaging accuracy, helping doctors better understand the spread of the disease and tailor treatments more effectively. This advancement in imaging could lead to earlier and more accurate interventions for patients with neuroblastoma.

What evidence suggests that 68Ga-DOTATATE imaging is effective for neuroblastoma?

Research has shown that 68Ga-DOTATATE is highly effective for imaging neuroblastoma, a type of cancer. One study found it superior to the commonly used 123I-MIBG in detecting bone lesions, identifying them in 97% of cases. Another study confirmed that 68Ga-DOTATATE PET/CT scans perform exceptionally well, particularly for patients with cancer spread to the central nervous system. This method offers a reliable option for determining the stage of neuroblastoma, with greater accuracy and sensitivity than other methods. The trial involves a single arm where all participants will undergo a PET scan with 68Ga-DOTATATE, making it a promising tool for doctors in evaluating this cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

Etienne Rousseau, MD, FRCPC

Principal Investigator

CIUSSSE-CHUS

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-DOTATATE

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

(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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40637785/

A head-to-head prospective comparative analysis of 68Ga- ... Conclusions: 68Ga-DOTATATE PET/CT demonstrated excellent diagnostic performance in NB and GNB patients with CNS metastases. Moreover, the ...

2. tech.snmjournals.org tech.snmjournals.org/content/49/3/265

68 Ga-DOTATATE PET/CT for Neuroblastoma Staging We have presented 68 Ga-DOTATATE PET/CT imaging for staging of neuroblastoma and believe it can reliably be used as an alternative to 123 I-MIBG.

3. frontiersin.org frontiersin.org/journals/nuclear-medicine/articles/10.3389/fnume.2022.825486/full

Normal Variants, Pitfalls and Artifacts in Ga-68 DOTATATE ... Conclusion. 68Ga-DOTATATE has become the new standard of imaging neuroendocrine tumors through a superior accuracy and high sensitivity as well as whole body ...

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

Neuroendocrine Tumor Diagnosis and Management Gallium-68-DOTATOC PET also showed better performance (higher sensitivity and similar specificity) than MRI for detecting primary tumors [3]. Gallium-68– ...

5. mdpi.com mdpi.com/2075-4426/11/4/270

Nuclear Medicine Imaging in Neuroblastoma [68Ga]Ga-DOTATATE was positive in all patients, whereas [123I]mIBG was positive in 40 patients. [68Ga]Ga-DOTATATE identified bone lesions in 97% (35/36) of the ...

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

Safety and accuracy of 68Ga-DOTATOC PET/CT in children ... Sensitivity of 68Ga-DOTATOC PET/CT was 88% (14 true positive, 2 false negative) and specificity was 100% (10 true negative, 0 false positive). 68Ga-DOTATOC PET/ ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5362940/

Safety and Efficacy of 68Ga-DOTATATE PET/CT ... No adverse events requiring treatment were observed. 68Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, ...

8. 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 ...

9. journals.lww.com journals.lww.com/nuclearmed/fulltext/2020/04000/the_complementary_role_of_68ga_dotatate_pet_ct_in.19.aspx

The Complementary Role of 68 Ga-DOTATATE PET/CT in ... Some authors suggest using 68 Ga-DOTATATE PET/CT for refractory neuroblastoma patients, which identifies additional disease compared with MIBG.