PET Imaging for Neuroendocrine Cancer

Overseen By Patrick Veit-Haibach, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Lung neuroendocrine tumors, Pregnancy, others

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

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve treatment plans for individuals with certain neuroendocrine tumors, specifically G2 and G3 gastroenteropancreatic neuroendocrine neoplasms. It employs PET scans with two types of tracers, including F18-FDG (Fluorodeoxyglucose F 18), to assess tumor activity and potential treatment responses. The goal is to identify patterns that assist doctors in selecting the best treatment strategy. This trial suits those diagnosed with these specific tumors, whether they have never received treatment or have undergone previous treatments. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance future treatment strategies.

Will I have to stop taking my current medications?

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

What prior data suggests that this PET imaging technique is safe for patients with neuroendocrine cancer?

Research has shown that 18F-FDG PET scans are commonly used for patients with neuroendocrine tumors. These scans help doctors assess tumor aggressiveness. Studies have found that 18F-FDG PET reliably identifies high-risk tumors, detecting when tumors are more advanced and may require more intensive treatment.

Regarding safety, 18F-FDG is generally well-tolerated, with no significant reports of serious side effects. This tracer is injected into the bloodstream to highlight areas where the body uses a lot of sugar, often indicating tumor activity.

Overall, 18F-FDG PET scans are a common and safe method for evaluating neuroendocrine tumors. Their safety is well-established, and they serve as a standard tool in assessing these types of cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using F18-FDG PET imaging for neuroendocrine cancer because it offers a more precise way to detect tumors compared to traditional imaging methods. Unlike standard imaging techniques, which can sometimes miss small or less active tumors, F18-FDG PET uses a radioactive tracer that highlights areas of high metabolic activity, common in cancer cells. This could lead to earlier and more accurate detection, potentially improving treatment outcomes and helping doctors tailor therapies more effectively.

What evidence suggests that PET imaging is effective for neuroendocrine cancer?

Research has shown that PET scans using a special type of glucose, called 18F-FDG, are crucial for understanding neuroendocrine tumors. In this trial, participants will undergo 18F-FDG PET/CT scans to assess tumor characteristics. Studies have found that patients with negative 18F-FDG scans often live longer than those with positive scans. The amount of 18F-FDG absorbed by the tumor can indicate cancer aggressiveness. For instance, a tumor that absorbs a lot of 18F-FDG is usually more aggressive. Conversely, if it absorbs less, the patient may experience better outcomes, such as longer survival and slower disease progression. This information aids doctors in creating better treatment plans for patients with neuroendocrine tumors. ^{1 2 5 6 7}

Who Is on the Research Team?

Ur Metser, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults with G2 or G3 well-differentiated gastroenteropancreatic neuroendocrine tumors. It's open to those who are treatment-naïve or have had previous treatments, provided they meet certain criteria like having a specific tumor grade and proliferation index. Pregnant women, patients with lung neuroendocrine tumors, Grade 1 tumors, poorly differentiated carcinomas, mixed cancers, or mental conditions affecting study comprehension are excluded.

Inclusion Criteria

My tumor is growing or dividing quickly.

I have a confirmed neuroendocrine tumor in my digestive system.

I have not been treated or have been treated for advanced cancer.

Exclusion Criteria

My cancer is a mix of neuroendocrine and non-neuroendocrine types.

My cancer is not a lung neuroendocrine tumor or related to non-digestive system cancers.

Any patient who is pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo dual-tracer PET imaging using 68Ga-DOTATATE and 18F-FDG to assess tracer uptake and tumor characteristics

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in clinical management and tumor characteristics based on imaging results

2 years

What Are the Treatments Tested in This Trial?

Interventions

• F18-FDG

Trial Overview The trial is studying the use of dual-tracer PET imaging using two substances (68Ga-DOTATATE and 18F-FDG) to differentiate between low-grade indolent and high-grade aggressive neuroendocrine tumors. The goal is to see if this imaging can guide treatment decisions and assess variability in tumor characteristics within the same patient.

How Is the Trial Designed?

Group I: 18F-FDG PETCT scan Experimental Treatment 1 Intervention

18F-FDG tracer (5 MBq/kg body weight of FDG; up to 550 MBq) will be injected into the intravenous

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Neuroendocrine Tumour Society (CNETS)

Collaborator

Trials

1

Recruited

40+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8069875/

Clinical Utility of 18F-FDG PET in Neuroendocrine Tumors ... Although, favorable outcomes in terms of treatment response and disease stabilization following PRRT were evident in both 18F-FDG negative and ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/62/6/808

18 F-FDG PET is Superior to WHO Grading as a Prognostic ... For patients receiving PRRT, 18F-FDG–negative cases had a significantly longer survival than 18F-FDG–positive cases, whereas no difference was ...

3. nature.com nature.com/articles/s41416-022-02061-5

Dual [68Ga]DOTATATE and [18F]FDG PET/CT in patients ... Median overall survival/time to progression was 101.8/25.5 months for P1, 46.5/16.7 months for P2–4, and 11.5/6.6 months for P5. Histological ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jne.13474

The role of combined FDG and SST PET/CT in ... After a median follow-up period of 36 months, the outcome was favorable, with a median OS not achieved and a median PFS of 48 months. When ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1930043324002541

Comparison of 18F-FDG PET/CT and 18F-DOTATATE PET ... This case report describes a 62-year-old male with a notable medical history, including surgically treated bladder cancer and the suspicion of metastatic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5813750/

Clinical Usefulness of 18F‐Fluorodeoxyglucose Positron ... This article reports on the ability of 18F‐FDG PET to identify cases of advanced entero‐pancreatic neuroendocrine neoplasms with more aggressive and unfavorable ...

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

Neuroendocrine Tumor Diagnosis and Management Comparison of the impact of 68Ga-DOTATATE and 18F-FDG PET/CT on clinical management in patients with neuroendocrine tumors. J Nucl Med 2017; 58:91–96. Go to ...