PET/CT Scans for Neuroendocrine Cancer

Overseen By Jonathan Abele, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Disqualifiers: Pregnant, Breastfeeding, Allergic to 18F-DOPA, 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: 3

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a single centre non-randomized non-blinded phase II prospective cohort study including 50 participants. The objective of this study is to directly compare 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG activity in patients with metastatic neuroendocrine tumors (NETs) on a lesion-by-lesion basis. The investigators will determine the prevalence of concordant versus discordant disease. Secondary objectives include assessing the standardized uptake value (SUV) and determining if there is any correlation between discordance and disease progression.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug 18F-DOPA for neuroendocrine cancer?

Research shows that 18F-DOPA PET scans are highly effective in detecting neuroendocrine tumors, such as carcinoid tumors and pheochromocytomas, with excellent sensitivity and accuracy. This helps doctors better locate and manage these tumors, improving treatment outcomes. ^{1 2 3 4 5}

Is 18F-DOPA PET/CT safe for humans?

The studies reviewed do not specifically address safety concerns, but 18F-DOPA PET/CT is widely used in imaging neuroendocrine tumors, suggesting it is generally considered safe for human use. ^{1 2 4 5 6}

How does the PET/CT scan treatment for neuroendocrine cancer differ from other treatments?

The PET/CT scan using 18F-DOPA is unique because it provides highly sensitive imaging for neuroendocrine tumors by taking advantage of the tumors' ability to absorb certain substances, making it more effective than conventional imaging methods. This approach is particularly useful for detecting tumors that might be missed by traditional scans, offering a more accurate diagnosis and aiding in better clinical management. ^{1 2 4 5 7}

Research Team

Jonathan Abele

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for adults aged 40 or older with a confirmed diagnosis of neuroendocrine tumors, including various types such as gastrointestinal, pancreatic, pulmonary NETs and others. Participants must have at least two abnormal lesions that are positive on a specific PET/CT scan. It's not suitable for those over 225 kg, with serious illnesses affecting the study outcome, previous allergic reactions to the imaging drug used in the trial (18F-DOPA), pregnant or breastfeeding women, or those unable to undergo scans.

Inclusion Criteria

Ability to provide written informed consent prior to participation in the study

I am 40 years old or older.

I have at least two lesions suspected to be a neuroendocrine tumor.

Exclusion Criteria

I am under 40 years old.

Any medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation

Previous allergic reaction to 18F-DOPA

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans to evaluate metastatic neuroendocrine tumors

1-2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for disease progression and treatment response

18 months

Periodic assessments

Treatment Details

Interventions

• 18F-DOPA

Trial Overview The study compares three different PET/CT imaging agents—68Ga-HA-DOTATATE, 18F-DOPA with furosemide, and 18F-FDG—to see which one better detects metastatic neuroendocrine tumors on a lesion-by-lesion basis. The goal is also to understand if differences in tumor detection correlate with disease progression.

Participant Groups

Group I: 18F-DOPA PET/CT scan Experimental Treatment 1 Intervention

4 MBq/kg (minimum 100 MBq, maximum 600 MBq) 18F-DOPA injected intravenously with 40 mg furosemide and subsequent whole body PET/CT scan

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

In a study of 22 patients with pancreatic endocrine tumors, PET imaging using carbon-11-labeled L-DOPA was effective in detecting tumor uptake, particularly in patients with metastatic disease, highlighting its potential as a diagnostic tool.

The combination of PET with both L-DOPA and hydroxytryptophan (5-HTP) showed promising results, with 5-HTP demonstrating higher uptake in some cases, suggesting it may enhance detection of certain tumors compared to L-DOPA alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic neuroendocrine tumors: diagnosis with PET. Ahlström, H., Eriksson, B., Bergström, M., et al.[2016]

18F-DOPA PET imaging has shown exceptional sensitivity in detecting neuroendocrine tumors, particularly in carcinoid tumors, and is effective in managing conditions like medullary thyroid cancer and pheochromocytoma.

While 18F-DOPA PET is promising for several neuroendocrine tumors, its value appears limited for some conditions, indicating a need for further research to fully understand its diagnostic capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

6-L-18F-fluorodihydroxyphenylalanine PET in neuroendocrine tumors: basic aspects and emerging clinical applications. Jager, PL., Chirakal, R., Marriott, CJ., et al.[2022]

The 18F-DOPA-PET/CT imaging technique demonstrated high sensitivity (91%) and specificity (96%) for detecting neuroendocrine tumors (NETs) in a study of 61 patients, significantly outperforming standard somatostatin receptor scintigraphy (SRS) which had a sensitivity of only 59%.

The use of 18F-DOPA-PET/CT led to changes in clinical management for 26% of patients, highlighting its significant impact on treatment decisions for those suspected of having NETs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of combined 6-[18F]fluorodihydroxyphenylalanine PET/CT for imaging of neuroendocrine tumours. Schiesser, M., Veit-Haibach, P., Muller, MK., et al.[2019]

In a study of 10 patients with confirmed hyperinsulinemic hypoglycemia, 18F-DOPA PET successfully localized pancreatic lesions in 9 out of 10 cases, which were later confirmed by histological analysis.

18F-DOPA PET demonstrated greater sensitivity than CT or MRI in identifying insulin-secreting tumors and beta-cell hyperplasia, making it a valuable diagnostic tool when other imaging methods yield negative results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) positron emission tomography as a tool to localize an insulinoma or beta-cell hyperplasia in adult patients. Kauhanen, S., Seppänen, M., Minn, H., et al.[2022]

In a pilot study of 22 patients suspected of having neuroendocrine tumors, fluorine-18-fluorodihydroxyphenylalanine (F-DOPA) PET scanning showed improved localization of tumors compared to conventional imaging methods.

F-DOPA PET results were concordant with final diagnoses in 16 out of 22 patients, indicating that this imaging technique can provide valuable information for clinical management, especially in cases with multiple abnormal findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18-fluorodihydroxyphenylalanine Positron-emission Tomography Scans of Neuroendocrine Tumors (Carcinoids and Pheochromocytomas). Zanzi, I., Studentsova, Y., Bjelke, D., et al.[2020]

In a study of 10 patients with gastroduodenal neuroendocrine neoplasms (NENs), 18F-FDOPA PET/CT was able to detect only 4 primary tumors, indicating that it may not be reliable for localizing these types of tumors, especially those smaller than 10 mm.

While 18F-FDOPA PET/CT successfully identified all patients with metastatic disease, it failed to detect lymph node metastases in some cases, suggesting that further multicenter trials are needed to better understand its effectiveness in assessing metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited role of carbidopa-assisted 18F-FDOPA PET/CT in patients with sporadic non-functional gastroduodenal neuroendocrine neoplasms. Imperiale, A., Averous, G., Helali, M., et al.[2020]

Contemporary PET/CT methods for detecting neuroendocrine tumors show significantly higher sensitivity (97%) compared to conventional methods (52%), meaning they can identify almost twice as many tumors.

Both methods have high specificity (92%), but the enhanced sensitivity of PET/CT makes it crucial for improving diagnosis and treatment planning for patients with neuroendocrine tumors, suggesting a need to replace conventional methods with these advanced techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contemporary nuclear medicine diagnostics of neuroendocrine tumors]. [2019]

References

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

Pancreatic neuroendocrine tumors: diagnosis with PET. [2016]

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

6-L-18F-fluorodihydroxyphenylalanine PET in neuroendocrine tumors: basic aspects and emerging clinical applications. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Value of combined 6-[18F]fluorodihydroxyphenylalanine PET/CT for imaging of neuroendocrine tumours. [2019]

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

Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) positron emission tomography as a tool to localize an insulinoma or beta-cell hyperplasia in adult patients. [2022]

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

Fluorine-18-fluorodihydroxyphenylalanine Positron-emission Tomography Scans of Neuroendocrine Tumors (Carcinoids and Pheochromocytomas). [2020]

6. Japan pubmed.ncbi.nlm.nih.gov

Limited role of carbidopa-assisted 18F-FDOPA PET/CT in patients with sporadic non-functional gastroduodenal neuroendocrine neoplasms. [2020]

7. Serbia pubmed.ncbi.nlm.nih.gov

[Contemporary nuclear medicine diagnostics of neuroendocrine tumors]. [2019]