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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new imaging method can better detect multiple myeloma (MM), a type of blood cancer that often recurs after treatment. Researchers are comparing a new tracer, 18F-fluciclovine injection, with the current standard, 18F-FDG PET/CT, to assess which is more effective in identifying the disease. Individuals with MM—whether newly diagnosed or with disease that has returned or not responded to treatment—might be suitable candidates. Participants will undergo various scans and tests to track the presence and progression of MM. As a Phase 2 trial, this research measures the effectiveness of the new imaging method in an initial, smaller group, offering participants a chance to contribute to advancements in MM detection.

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 the 18F-fluciclovine PET/CT scan is safe for detecting multiple myeloma?

Research shows that 18F-fluciclovine, used in PET/CT scans, holds promise for imaging multiple myeloma, a type of blood cancer. Although specific safety data for 18F-fluciclovine in humans with this condition is lacking, the FDA has approved it for other uses, suggesting potential safety. However, further studies are necessary to confirm this for multiple myeloma. In this trial, researchers will closely monitor safety from the time of injection up to three days after, checking for any side effects during this period. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-fluciclovine PET/CT scan for multiple myeloma because it offers a fresh approach to imaging compared to traditional 18F-FDG PET/CT scans. Unlike the standard method that primarily highlights glucose uptake, 18F-fluciclovine targets amino acid transport, potentially providing clearer insights into tumor activity and progression. This new technique could improve the accuracy of detecting multiple myeloma, helping doctors tailor treatments more effectively for patients.

What evidence suggests that the 18F-fluciclovine PET/CT scan is effective for detecting multiple myeloma?

Research has shown that the radiotracer 18F-fluciclovine holds promise in detecting multiple myeloma (MM), a type of blood cancer. One study found that 18F-fluciclovine PET/CT scans identified more cases of MM (92%) compared to standard 18F-FDG PET/CT scans (69%). This finding suggests that 18F-fluciclovine may be more effective at detecting the disease. Early detection of MM is crucial, as it can lead to better treatment outcomes. Participants in this trial will undergo 18F-fluciclovine PET/CT scans to assess its effectiveness in detecting MM at various timepoints. Although 18F-fluciclovine is already used for prostate cancer, its potential for identifying MM is gaining attention due to these promising results. ^{1 2 5 6 7}

Who Is on the Research Team?

Elizabeth M Hill, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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

Women of childbearing potential need to have a negative pregnancy test before joining the study.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06103838

18F-Fluciclovine PET/CT in Multiple Myeloma 18F-fluciclovine is a radionuclide approved by the FDA for evaluating suspected prostate cancer recurrence but has shown additional ability in detecting MM ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9581841/

Comparison of [18F]fluciclovine and [18F]FDG PET/CT in ... Our results support this theoretical notion and demonstrate that [18F]fluciclovine is indeed a promising tracer for MM. A recent study investigated [11C] ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-imaging-multiple-myeloma-patients-using-fluciclovine-18f-pet-ct/

Study on Imaging Multiple Myeloma Patients Using ... This clinical trial investigates the effectiveness of Fluciclovine (18F) PET/CT in detecting multiple myeloma, a type of bone marrow cancer, ...

4. withpower.com withpower.com/trial/phase-2-neoplasms-plasma-cell-10-2023-f316c

18F-Fluciclovine PET/CT Scan for Multiple Myeloma 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%), ...

5. link.springer.com link.springer.com/article/10.1007/s40336-025-00714-y

PET radiopharmaceuticals beyond 2-[18F]FDG for the ... In fact, follow-up [18F]NaF PET/CT showed persistence of 81.5% of the baseline [18F]NaF positive MM lesions after treatment, despite the fact ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8804025/

Initial evaluation of [18F]-FACBC for PET imaging ... The FDA/EMA approved PET agent [ 18 F]-FACBC is promising for imaging MM and should be further evaluated in prospective clinical studies.

7. ancora.ai ancora.ai/fr/details/NCT06103838

18F-Fluciclovine PET/CT in Multiple Myeloma All participants will be evaluable for toxicity from the time at each 18F-fluciclovine dose through 3 days after each dose. Safety of the agents will be ...