Ultralow Dose PET Imaging for Cancer

Overseen By Dianna Willis, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Akiva Mintz

Must not be taking: SSTR targeted therapies

Disqualifiers: Radiation exposure, Claustrophobia, Chronic pain, 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

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for using PET scans to detect and monitor neuroendocrine tumors with significantly less radiation. The researchers aim to maintain the scans' effectiveness while reducing the radiation dose by 10 to 100 times. Participants will receive a small amount of a special tracer, 68Ga-Dotatate, which binds to a protein in these tumors, and then undergo scans for up to 3 hours. This trial suits individuals with neuroendocrine tumors who can tolerate long scan durations and have not been exposed to excessive radiation from previous tests. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in safer imaging techniques.

What prior data suggests that this imaging technique is safe for neuroendocrine tumor detection?

Research shows that 68Ga-Dotatate is generally safe for PET scans. The FDA has approved this substance for detecting neuroendocrine tumors at normal doses. Studies have found that patients tolerate it well, with side effects being rare and usually mild, such as minor reactions at the injection site or slight nausea.

In this trial, researchers will use a very low dose of 68Ga-Dotatate, reducing participants' radiation exposure. The goal is to determine if the images remain clear with this lower dose, potentially making the process even safer by further minimizing any risks. Overall, this treatment has a strong safety record, and the study aims to enhance it further. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultralow dose PET imaging for cancer because it dramatically reduces radiation exposure compared to traditional PET scans. This technique uses the radiotracer 68Ga-Dotatate, but with doses that are 10 to 100 times lower than standard methods. The goal is to maintain high-quality imaging while minimizing the risks associated with radiation. By optimizing the timing and reconstruction of images, this approach could make cancer imaging safer and more accessible, offering a significant advancement in diagnostic technology.

What evidence suggests that this ultralow dose PET imaging technique is effective for neuroendocrine tumor detection?

Studies have shown that 68Ga-Dotatate effectively detects neuroendocrine tumors. It uses a small amount of radioactive material that attaches to a specific protein in these tumors. Research indicates that this imaging method can alter treatment plans for about 36% of patients due to its greater accuracy and reduced radiation exposure. In this trial, participants will join an ultralow dose 68Ga-Dotatate imaging group to evaluate image quality and optimize timing and reconstruction after reducing radiation doses by 10- to 100-fold. 68Ga-Dotatate PET scans have proven superior to MRI in identifying both primary and metastatic tumors, making it a powerful tool for diagnosing and managing neuroendocrine cancers. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for both healthy individuals and patients with neuroendocrine tumors. It aims to test a new PET scan method that uses much less radiation. Participants will be injected with a tracer and scanned for up to 3 hours.

Inclusion Criteria

I am 18 years old or older.

For female participants: Must not be pregnant or breastfeeding; Negative pregnancy test required for women of childbearing potential

Ability to provide informed consent and comply with study procedures

Exclusion Criteria

Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.

Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 millisievert [mSv] total)

More than four prior enrollments in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo ultralow dose PET imaging to evaluate image quality and optimize timing and reconstruction

Up to 3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

12 months

Annual evaluation based on pooled images

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-Dotatate

Trial Overview

The study is testing the effectiveness of an ultralow dose PET imaging technique using the radiotracer 68Ga-Dotatate, which targets somatostatin receptor 2 (SSTR2) in tumor cells.

How Is the Trial Designed?

Group I: Ultralow dose 68Ga-DOTATATE imaging group Experimental Treatment 1 Intervention

Participants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours

Who Is Running the Clinical Trial?

Akiva Mintz

Lead Sponsor

Trials

1

Recruited

40+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07284589?cond=cancer

Ultralow Dose PET Imaging of SSTR2 Radiotracer Uptake

The radiotracer, Gallium-68 (68Ga)-Dotatate, is FDA-approved for detecting neuroendocrine cancer at standard doses.

2.

pmc.ncbi.nlm.nih.gov

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

Safety and Efficacy of 68Ga-DOTATATE PET/CT ...

Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared ...

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 68Ga-DOTATATE PET/CT and describes its role in the diagnostic algorithm ...

4.

auntminnie.com

auntminnie.com/resources/conference/snmmi/2024/article/15676965/snmmi-petct-is-superior-to-mri-for-detecting-head-and-neck-paragangliomas

SNMMI: PET/CT is superior to MRI for detecting head and ...

Gallium-68 (Ga-68) DOTATATE PET/CT may be more effective than MRI for assessing head and neck paragangliomas, according to a study.

5.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1675974/full

Ga-68 DOTATATE PET imaging in the management of ...

Results: Ga-68 DOTATATE PET/CT demonstrated enhanced sensitivity in detecting both primary and metastatic lesions compared to MRI and other imaging modalities.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07284589

Ultralow Dose PET Imaging of SSTR2 Radiotracer Uptake

The radiotracer, Gallium-68 (68Ga)-Dotatate, is FDA-approved for detecting neuroendocrine cancer at standard doses.

7.

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 ...

8.

uwmedicine.org

uwmedicine.org/sites/stevie/files/2019-08/PET-CT-Ga-68-Dotatate-Mid-body-Study.pdf

PET/CT Ga-68 Dotatate Scan

What is a PET/CT Ga-68 dotatate scan? This scan is done to diagnose neuroendocrine tumors, which involve both the nervous system and the endocrine glands.

9.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-09392

Total-body PET/CT (EXPLORER) with Different ...

... DOTATATE or 68Ga-DOTATATE IV and undergo dynamic PET scan over up to 90 minutes. Patients also undergo ultra-low dose CT scan followed by static PET scan ...