18F-MFBG Imaging for Neuroendocrine Cancer

Overseen By Shakeel Modak, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Major organ toxicity, Active infections, Uncontrolled illness, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging tracer, 18F-MFBG, to evaluate its effectiveness in highlighting neuroendocrine tumors during PET scans. Researchers aim to understand the tracer's movement through the body and its duration in the blood. The trial includes individuals with neuroendocrine tumors or neuroblastoma who have shown positive results on previous MIBG scans. Participants must undergo a PET scan without sedation. As a Phase 1, Phase 2 trial, participants will be among the first to help researchers understand how this new tracer functions and assess its effectiveness in highlighting tumors.

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 patients should not have received chemotherapy or radiation therapy between certain scans. It's best to discuss your specific medications with the study team.

What prior data suggests that 18F-MFBG and PET Imaging are safe for use in this trial?

Research shows that 18F-MFBG, a new imaging substance, is generally safe for people. Earlier studies with patients found no major safety problems. When 18F-MFBG was used for PET scans to detect certain types of tumors, participants did not experience serious side effects. The substance helps doctors visualize tumors during a PET scan and appears to do so safely. While these results are encouraging, it's important to remember that this is still a trial, so researchers continue to learn more about its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-MFBG imaging for neuroendocrine cancer because it offers a more precise way to visualize tumors compared to traditional imaging methods. Unlike standard imaging techniques, which might not clearly differentiate between tumor and non-tumor tissues, 18F-MFBG is a radiotracer specifically designed to target neuroendocrine tumors. This targeted approach allows for more accurate detection and assessment of tumor spread using PET imaging, potentially leading to earlier and more effective treatment decisions. Additionally, the use of non-invasive PET scans with 18F-MFBG provides detailed insights into the distribution and behavior of the tumors in the body, which is a significant advancement over conventional imaging methods.

What evidence suggests that 18F-MFBG is effective for imaging neuroendocrine cancer?

This trial will evaluate the use of 18F-MFBG for detecting neuroendocrine tumors. Studies have shown that 18F-MFBG holds promise for this purpose. One study found that using 18F-MFBG with PET scans improved the detection of these tumors. This imaging tracer highlights cancer spots in the body more clearly. Research also indicates that 18F-MFBG effectively detects neuroblastoma in bones and soft tissues. These findings suggest that 18F-MFBG could be a useful tool in identifying neuroendocrine cancers. ^{1 2 6 7 8}

Who Is on the Research Team?

Neeta Pandit-Taskar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with certain neuroendocrine tumors, such as paraganglioma and neuroblastoma, who are over 5 years old and can have a PET scan without sedation. They must show signs of the tumor on a specific type of scan (MIBG) and not have severe organ damage or other serious illnesses.

Inclusion Criteria

Phase I: Eligible patients include patients with histologically proven Neuroendocrine tumors (paraganglioma, PHEO, or well differentiated NET of the lung or GI system) or NB. Patients who have NB, the diagnosis must be in accordance with the International Criteria, i.e., either histopathology or bone marrow involvement. Patients must be ≥5 years of age and able to undergo PET scan without sedation. All patients must have MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol. Performance status of ≥60 on Karnofsky scale for patients >16 years of age and >60 on Lansky scale for patients <16 years of age. Cardiac, pulmonary, gastrointestinal and neurologic toxicity should all be ≤grade 2.

Expansion Cohort: Patients with diagnosis of NB (in accordance with the International Criteria, i.e., either histopathology or bone marrow involvement). Patients must be able to undergo PET scan without sedation. Patients must have prior MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol. If MIBG scan is available within 4 weeks of MFBG, with no intervening treatment, MIBG scan will not be repeated. If prior MIBG scan is available >4 weeks of MFBG, MIBG scan will be done within a week (prior or after) of MFBG. Performance status of ≥60 on Karnofsky scale for patients >16 years of age and >60 on Lansky scale for patients ≤16 years of age. Cardiac, pulmonary, gastrointestinal and neurologic toxicity should all be ≤grade 2. Patients with positive lesion detection by 18F-MFBG may be eligible for repeat imaging scan, at the discretion of PI or study investigator(s).

Exclusion Criteria

Major organ toxicity including cardiac, pulmonary, gastrointestinal and neurologic toxicity more than grade 2. Active serious infections not controlled by antibiotics. Inability or unwillingness to undergo PET scanning. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Women who are pregnant or breastfeeding. Patient has an active malignancy of metastatic potential other than the known NE tumor for the past 3 years. Patients should not have received chemotherapy or radiation therapy (localized radiation therapy is allowed to non-evaluable sites) between prior 123I-MIBG scan and 18F-MFBG administration. Patients requiring anesthesia, who are not already undergoing anesthesia for standard-of-care procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I

A single dose of 18F-MFBG is injected intravenously, followed by pharmacokinetics and bio distribution evaluation using non-invasive PET scanning and blood assays at multiple time points post-injection.

1-2 weeks

Multiple visits for PET scanning and blood assays

Expansion Phase

A single dose of 18F-MFBG is injected intravenously, followed by a single time point imaging using PET MR scanner or PET/CT. Additional imaging for patients showing lesion detection.

1-2 weeks

1 visit for PET MR or PET/CT scan, optional repeat imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment, including lesion detection evaluation and dosimetry analysis.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• 18F-MFBG
• Positron Emission Tomography (PET) Imaging

Trial Overview Researchers are testing a new imaging agent called 18F-MFBG to see how it distributes in the body, its elimination process, and if it's effective at showing neuroendocrine tumors on PET scans. Participants will undergo PET imaging and blood tests.

How Is the Trial Designed?

Group I: pts with primary or metastatic neuroendocrine tumors Experimental Treatment 3 Interventions

For phase I, a single dose of 18F-MFBG will be injected intravenously in patients. For all patients, pharmacokinetics and bio distribution will be evaluated using non invasive PET scanning and blood assays at multiple time points post injection. In the expansion phase, a single dose of 18F-MFBG will be injected intravenously followed by a single time point imaging using PET MR scanner or PET/CT. In expansion cohort, an additional 50 patients with NB will be imaged. Patients will receive a single dose of 18F-MFBG intravenously, followed by a whole body PET scan on PET/CT or PET/CT scanner at 60-90 minutes post injection. Patients who show lesion detection by MFBG may be eligible for repeat imaging scan with 18 F- MFBG, at the discretion of PI or study investigator(s). All parameters and technical details of scanning will be as per the study and first imaging.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02348749

18F-MFBG Imaging for Evaluation of Neuroendocrine ... The purpose of this study is to see how a new tracer named 18F-MFBG (Meta Fluorobenzyl Guanidine) behaves in the body after injection, how it spreads to all ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5750519/

A First-in-Human PET/CT Imaging Study of Patients with ... We conducted a first-in-human study of 18F-MFBG PET imaging to evaluate the safety, feasibility, pharmacokinetics, and dosimetry of 18F-MFBG in ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/252135

Evaluating the Efficacy of 18F-MFBG PET/CT in Differentiating ... Thoracic PET/CT imaging was performed 1-2 hours after 18F-MFBG injection. 10 patients also underwent 131I-MIBG scintigraphy at early (15-minutes) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12487752/

Lesion Analysis of 18F-Metafluorobenzylguanidine PET ... Other groups have reported similar findings on the kinetics of 18F-MFBG (9) and improved detection of lesions in neuroendocrine tumors (10,11).

5. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251462.abstract

18F-mFBG PET in High-Risk Neuroblastoma Research experience with 18F-mFBG PET has consistently demonstrated increased detection of neuroblastoma lesions in bone and soft tissue ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39641193/

Safety observations in neuroblastoma patients undergoing ... In this investigation of the potential clinical utility of m FBG PET imaging, no significant adverse safety signals were noted.

7. researchgate.net researchgate.net/publication/386504819_Safety_observations_in_neuroblastoma_patients_undergoing_18F-mFBG_PET

Safety observations in neuroblastoma patients undergoing ... Objective Limited safety data have been published on fluorine-18 ( ¹⁸ F) meta-fluorobenzylguanidine ( m FBG), a new PET radiopharmaceutical for imaging ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04258592

Study Details | NCT04258592 | 18F-MFBG PET Imaging of ... A single dose of 18F-MFBG will be intravenously injected in 10 patients with neural crest tumors or neuroendocrine tumors. Adult patients will first undergo ...