18F-Fluciclovine PET/CT Scan for Multiple Myeloma

Overseen By Elizabeth M Hill, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Oral anxiolytics

Disqualifiers: Allergies, Claustrophobia, Uncontrolled illness, 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: 4

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier. Objective: To find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose. Eligibility: Adults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM). Design: Participants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET/CT scan takes images of their body. All participants will have 3 study visits. During each visit they will have: Two PET/CT scans. One with 18F-FDG, one with 18F-fluciclovine. An optional magnetic resonance imaging scan. A bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone. These tests may be spread over 30 days for each visit. NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first. All participants will have a third study visit after 5 years or when their disease progresses.

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 data supports the effectiveness of the treatment 18F-Fluciclovine PET/CT Scan for Multiple Myeloma?

Research shows that PET/CT scans using 18F-FDG (a type of imaging test) are effective in diagnosing and monitoring multiple myeloma by detecting bone lesions and providing important prognostic information. While 18F-Fluciclovine is being explored as an alternative, 18F-FDG PET/CT is currently considered a reliable tool for assessing the disease. ^{1 2 3 4 5}

Is the 18F-Fluciclovine PET/CT scan safe for humans?

The research does not provide specific safety data for 18F-Fluciclovine PET/CT scans, but similar PET/CT scans like 18F-FDG PET/CT are widely used and generally considered safe for humans. ^{1 2 6 7 8}

How does the 18F-Fluciclovine PET/CT scan differ from other treatments for multiple myeloma?

The 18F-Fluciclovine PET/CT scan is unique because it uses a different tracer than the commonly used 18F-FDG PET/CT, potentially offering better imaging for certain types of lesions in multiple myeloma. This alternative tracer may help overcome some limitations of the standard FDG PET/CT, providing a new perspective in the imaging of this condition. ^{1 2 4 6 9}

Research Team

Elizabeth M Hill, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Adults over 18 with Multiple Myeloma (MM), either newly diagnosed or having relapsed after treatment, can join this trial. They must have measurable disease and be in relatively good health (ECOG <=2). Women who can bear children and men must use contraception. People with severe allergies to the study drugs, uncontrollable claustrophobia, serious illnesses that could affect participation, or breastfeeding mothers cannot participate.

Inclusion Criteria

Ability of subject to understand and the willingness to sign a written informed consent document

I am 18 years old or older.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I am allergic to certain imaging agents similar to 18F-FDG or 18F-fluciclovine.

Uncontrolled intercurrent illness including psychiatric illness/social situations that would limit compliance with study requirements

I will stop breastfeeding if I receive 18F-fluciclovine treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Imaging and Testing

Participants undergo initial PET/CT scans with 18F-FDG and 18F-fluciclovine, optional MRI, and bone marrow biopsy

4 weeks

1 visit (in-person)

Second Imaging and Testing

NDMM participants have second visit 2-4 weeks after treatment; RRMM participants have second visit 6 months after first

2-4 weeks for NDMM, 6 months for RRMM

1 visit (in-person)

Long-term Follow-up

Participants have a third study visit after 5 years or when their disease progresses

5 years or until disease progression

1 visit (in-person)

Treatment Details

Interventions

• 18F-FDG PET/CT
• 18F-fluciclovine injection

Trial Overview The trial is testing if a new imaging agent called 18F-fluciclovine is better at detecting MM than the current standard agent, 18F-FDG. Participants will undergo PET/CT scans using both agents and may also have an MRI scan and bone marrow biopsy. The tests are spread out over three visits within five years or until disease progression.

Participant Groups

Group I: 18F-fluciclovine PET/CT in Multiple Myeloma Experimental Treatment 2 Interventions

Evaluate 18F-fluciclovine PET/CT in participants with multiple myeloma at Timepoint #1, Timepoint #2 ( after induction treatment (NDMM) or six months (RRMM)) and at Timepoint #3 (the time of progression or 5 years).

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 13 newly diagnosed multiple myeloma patients, [18F]fluciclovine PET/CT detected more positive cases (92%) compared to [18F]FDG PET/CT (69%), suggesting that [18F]fluciclovine may be more effective for identifying disease.

[18F]fluciclovine PET/CT provided clearer images and higher lesion uptake values than [18F]FDG PET/CT, indicating its potential superiority in visual interpretation and quantification of multiple myeloma lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of [18F]fluciclovine and [18F]FDG PET/CT in Newly Diagnosed Multiple Myeloma Patients. Stokke, C., Nørgaard, JN., Feiring Phillips, H., et al.[2022]

FDG-PET imaging is a highly sensitive and specific tool for detecting bone lesions in multiple myeloma patients, providing important prognostic information regarding progression-free survival and overall survival based on baseline parameters.

FDG-PET is essential for therapeutic evaluation, as it can detect persistent disease activity before maintenance therapy, and it may guide treatment decisions in smoldering multiple myeloma by identifying hyper-metabolic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest of Pet Imaging in Multiple Myeloma. Jamet, B., Bailly, C., Carlier, T., et al.[2020]

PET/CT imaging is a highly sensitive and reliable tool for diagnosing multiple myeloma and assessing how well patients respond to treatments like chemotherapy and radiotherapy.

This imaging technique not only helps identify bone lesions and soft-tissue masses but also provides important prognostic information that can guide the management of myeloma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET with Fluorodeoxyglucose F 18/Computed Tomography as a Staging Tool in Multiple Myeloma. Seval, GC., Ozkan, E., Beksac, M.[2019]

In a study of 66 patients suspected of having multiple myeloma, (18)F-FDG-PET/CT demonstrated a high sensitivity of 100% for diagnosing the disease, making it a highly effective diagnostic tool.

The study found that (18)F-FDG-PET/CT not only accurately diagnosed multiple myeloma but also effectively located and counted disease foci, which can aid in evaluating treatment efficacy and guiding clinical decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic Value of (18)F-FDG-PET/CT for Multiple Myeloma]. Li, JQ., Guan, LL., Wang, J., et al.[2018]

Recent advances in the diagnosis and treatment of multiple myeloma (MM) have highlighted the effectiveness of imaging techniques, particularly CT and MRI, for initial assessment.

Emerging evidence suggests that PET/CT using 18F-deoxyglucose (FDG) may offer superior capabilities for staging and monitoring treatment response in MM, indicating a potential shift in standard imaging practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET Imaging for Initial Staging and Therapy Assessment in Multiple Myeloma Patients. Bailly, C., Leforestier, R., Jamet, B., et al.[2019]

In a pilot study involving 8 patients with multiple myeloma, 18F-FDG PET/CT was found to be significantly more effective than 18F-FLT PET/CT in detecting myeloma-indicative lesions, identifying 48 lesions compared to only 17 with 18F-FLT.

The study revealed a mismatch between 18F-FDG and 18F-FLT uptake in some lesions, suggesting that while 18F-FLT shows higher uptake values, it may not be suitable as a standalone tracer for diagnosing multiple myeloma due to high background activity and lower detection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of glucose metabolism and cellular proliferation in multiple myeloma: a first report on combined 18F-FDG and 18F-FLT PET/CT imaging. Sachpekidis, C., Goldschmidt, H., Kopka, K., et al.[2020]

FDG-PET imaging can detect multiple myeloma lesions in patients with negative radiographs, identifying 23% of newly diagnosed cases that required therapy, which highlights its potential role in initial staging.

The study suggests that FDG-PET is useful for monitoring patients in remission, as it can indicate relapses or other malignancies, with a median follow-up of 14 to 15 months showing good prognostic significance in asymptomatic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The value of fluorodeoxyglucose positron emission tomography in multiple myeloma]. Adam, Z., Bolcák, K., Stanícek, J., et al.[2016]

In patients with multiple myeloma, 18F-FDG PET/CT and 18F-NaF PET/CT can show different patterns of uptake, indicating that they may provide complementary information about bone lesions.

One patient exhibited intense 18F-FDG uptake in skeletal lesions while 18F-NaF appeared normal, suggesting that FDG may be more sensitive for detecting active disease, while NaF may highlight different aspects of bone involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different lesions revealed by 18F-FDG PET/CT and 18F-NaF PET/CT in patients with multiple myeloma. Xu, F., Liu, F., Pastakia, B.[2018]

In a study involving 7 patients with multiple myeloma, (18)F-fluoride PET/CT detected 89% of the lesions identified by the reference standard, significantly outperforming (99m)Tc-MDP bone scintigraphy, which only detected 58%.

The (18)F-fluoride PET/CT not only identified more lesions but also revealed additional bone fractures, suggesting it may be a more effective imaging modality for assessing multiple myeloma lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of 18F-fluoride PET/CT in the assessment of multiple myeloma: initial experience. Nishiyama, Y., Tateishi, U., Shizukuishi, K., et al.[2022]

References

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

Comparison of [18F]fluciclovine and [18F]FDG PET/CT in Newly Diagnosed Multiple Myeloma Patients. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Interest of Pet Imaging in Multiple Myeloma. [2020]

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

PET with Fluorodeoxyglucose F 18/Computed Tomography as a Staging Tool in Multiple Myeloma. [2019]

4. China pubmed.ncbi.nlm.nih.gov

[Diagnostic Value of (18)F-FDG-PET/CT for Multiple Myeloma]. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

PET Imaging for Initial Staging and Therapy Assessment in Multiple Myeloma Patients. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Assessment of glucose metabolism and cellular proliferation in multiple myeloma: a first report on combined 18F-FDG and 18F-FLT PET/CT imaging. [2020]

7. Czech Republic pubmed.ncbi.nlm.nih.gov

[The value of fluorodeoxyglucose positron emission tomography in multiple myeloma]. [2016]

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

Different lesions revealed by 18F-FDG PET/CT and 18F-NaF PET/CT in patients with multiple myeloma. [2018]

9. Japan pubmed.ncbi.nlm.nih.gov

Role of 18F-fluoride PET/CT in the assessment of multiple myeloma: initial experience. [2022]