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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a special type of medical scan detects neuroendocrine tumors, rare cancers that can appear in various body parts. Researchers will use a PET/CT scan with a tracer called 18F-DOPA (a radiolabeled compound) to compare its effectiveness with other scans in identifying these tumors. The trial seeks participants diagnosed with neuroendocrine tumors who have had at least two abnormal scan results previously. As a Phase 2 trial, the research focuses on assessing 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 whether you need to stop taking your current medications.

What prior data suggests that PET/CT scans are safe for neuroendocrine cancer patients?

Research has shown that 18F-DOPA PET scans offer a promising method for diagnosing certain types of tumors. Studies have found that 18F-DOPA is generally safe and well-tolerated by patients, with no major reports of serious side effects in medical settings, indicating its relative safety. However, as with any medical procedure, minor side effects can occur, though they are usually not serious. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for neuroendocrine cancer, which typically includes treatments like chemotherapy, targeted therapy, or somatostatin analogs, the 18F-DOPA PET/CT scan is a diagnostic technique rather than a direct treatment. Researchers are excited about this approach because it uses the novel active ingredient 18F-DOPA, which is injected intravenously to highlight neuroendocrine tumors during the scan. This method could potentially allow for more precise imaging of cancerous cells, helping doctors to better understand the extent and activity of the disease. By offering detailed whole-body scans, this technique could lead to more accurate diagnoses and tailored treatment plans for patients.

What evidence suggests that this trial's treatments could be effective for neuroendocrine cancer?

Research has shown that 18F-DOPA PET/CT scans effectively image neuroendocrine tumors (NETs). This scanning method uses a special substance to highlight tumors in the images. In this trial, participants will undergo the 18F-DOPA PET/CT scan, which involves intravenous injection of 18F-DOPA. Studies have found that 18F-DOPA PET/CT can alter treatment plans for many patients with brain tumors, suggesting its potential usefulness for other tumor types as well. The substance is absorbed by tumor cells, allowing doctors to see the tumors more clearly and make better treatment decisions. This technique is praised for providing clear and accurate images. Overall, 18F-DOPA PET/CT is considered a promising tool for better understanding and managing neuroendocrine tumors. ^{1 6 7 8 9}

Who Is on the Research Team?

Jonathan Abele

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22323780/

Impact of 3,4-dihydroxy-6-18F-fluoro-L-phenylalanine PET ... (18)F-DOPA PET/CT changed the intended management of 41% of patients with brain tumors, and intended management changes were implemented in 75% of these.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11989814/

A Practical, Short, [18F]F-DOPA PET/CT Acquisition Method ... A simple, static [ 18 F]F-DOPA PET/CT acquisition, starting 1.5 min after injection and lasting less than five minutes, permitted reaching excellent diagnostic ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/49/4/573

6-l-18F-Fluorodihydroxyphenylalanine PET in ... 18 F-DOPA PET is a new diagnostic tool for the imaging of various neuroendocrine tumors. This amino acid tracer is taken up through ubiquitous transmembrane ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0969805111001867

DA and [18F]-DOPA for PET imaging in a mouse model of ... To evaluate the usefulness of [18F]-6-fluorodopamine ([18F]-DA) and [18F]-L-6-fluoro-3,4-dihydroxyphenylalanine ([18F]-DOPA) positron emission tomography ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/jnumed/49/4/573.full.pdf

6-L-18F-Fluorodihydroxyphenylalanine PET in ... Therefore, the aim of this review was to summarize current knowledge on the application of whole- body imaging with 18F-DOPA PET in neuroendocrine tumors. For ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18344441/

6-L-18F-fluorodihydroxyphenylalanine PET in ... In recent years, 6-l-18F-fluorodihydroxyphenylalanine (18F-DOPA) PET has emerged as a new diagnostic tool for the imaging of neuroendocrine tumors.

7. jnm.snmjournals.org jnm.snmjournals.org/content/56/1/106.short

In Vivo Biodistribution of No-Carrier-Added 6- 18 F-Fluoro-3,4 ... A novel synthetic approach to 6-18F-fluoro-3,4-dihydroxy-l-phenylalanine (18F-DOPA), involving the nucleophilic substitution of a diaryliodonium ...

8. aacrjournals.org aacrjournals.org/cancerres/article/68/17/7183/540587/Manipulation-of-11C-5-Hydroxytryptophan-and-6-18F

5-Hydroxytryptophan and 6-[18F]Fluoro-3,4-Dihydroxy-l ... The aim of the present study was the analysis of the uptake of [11C]HTP and [18F]FDOPA by LAT, peripheral decarboxylation by amino acid ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6791383/

A side-by-side evaluation of [18F]FDOPA enantiomers for non ... Cumulatively our results indicate the potential diagnostic applications of D-[18F]FDOPA for malignancies where the utility of L-[18F]FDOPA-PET ...