18F-DCFPyL PET/CT Scan for Liver Cancer

Overseen By Freddy E Escorcia, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must be taking: Antiretrovirals, HBV suppressive therapy

Disqualifiers: Allergies, Uncontrolled illness, Claustrophobia, 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: 8

7 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: A radiotracer (or tracer) is a radioactive substance. It is used in Positron Emission Tomography (PET) imaging to help see specific sites in the body. Researchers want to learn if a new tracer can help them better identify hepatocellular cancer (HCC) in people. Objective: To learn if a radiotracer called 18F-DCFPyL can identify sites of HCC better than current standard imaging. Eligibility: Adults aged 18 years and older who may have HCC based on previous standard imaging. Design: Participants will be screened with a medical history, physical exam, and blood tests. They will have a computed tomography (CT) and/or magnetic resonance imaging (MRI) scan. Participants will have a whole-body PET/CT scan. The PET and CT scanners use x-rays to make pictures of the inside of the body. The PET uses a tracer to help make the pictures. Participants will get an intravenous (IV) injection of 18F-DCFPyL 1 hour before the scan. Within two weeks, participants will have a 18F-FDG PET/CT scan. 18F-FDG is a commonly used tracer. They will get 18F-FDG via IV 1 hour before the scan. Participants will have a CT/MRI within 2 months of the first 18F-DCFPyL PET/CT. Participants will have standard treatment for their cancer. During treatment, they will have a tumor biopsy. If the biopsy shows they do not have HCC, they will be removed from the study. For participants who have HCC and their cancer was identified in the 18F-DCFPyL PET/CT, they will have a second 18F-DCFPyL PET/CT and 18F-FDG PET/CT. Participants will have follow-up visits every 3 months for 2 years. Then they will have yearly visits for 3 years.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on anti-retroviral therapy for HIV or suppressive therapy for hepatitis B, you must continue these treatments to participate.

What data supports the effectiveness of the treatment 18F-DCFPyL PET/CT Scan for Liver Cancer?

The research suggests that MRI enhanced with mangafodipir trisodium (a contrast agent) is effective in detecting and characterizing liver lesions, often providing more diagnostic information than CT scans. This implies that advanced imaging techniques, like the 18F-DCFPyL PET/CT scan, could potentially offer similar or improved diagnostic capabilities for liver cancer. ^{1 2 3 4 5}

How does the 18F-DCFPyL PET/CT scan treatment for liver cancer differ from other treatments?

The 18F-DCFPyL PET/CT scan is unique because it uses a specific tracer for imaging liver cancer, potentially offering more precise detection compared to standard imaging methods like MRI or CT, which may struggle with smaller tumors or in patients with other liver conditions. ^{4 6 7 8 9}

Research Team

Freddy E Escorcia, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Adults who may have hepatocellular carcinoma (HCC) based on previous imaging, can take oral meds and follow the study plan. They must use contraception if of childbearing potential. Excluded are those with severe claustrophobia, high creatinine levels, unstable health conditions, or weight over 350 lbs.

Inclusion Criteria

I can take pills and will follow the study's treatment plan.

I am a candidate for treatments targeting specific areas of my cancer.

I had hepatitis C but have been treated and cured.

Exclusion Criteria

I have severe claustrophobia that doesn't improve with anxiety medication.

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL or other agents used in study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Imaging

Participants undergo a baseline 18F-DCFPyL PET/CT scan and a standard of care CT and/or MRI

2 months

2 visits (in-person)

Treatment and Biopsy

Participants receive standard treatment for HCC and undergo a tumor biopsy

Varies based on treatment

1 visit (in-person)

Post-treatment Imaging

Participants with positive baseline imaging undergo post-treatment 18F-DCFPyL PET/CT imaging

16 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 3 months for 2 years, then yearly for 3 years

Treatment Details

Interventions

• CT
• F18-DCFPyL
• F18-FDG
• MRI

Trial Overview The trial is testing a new radiotracer called 18F-DCFPyL for identifying HCC compared to the standard tracer 18F-FDG. Participants will undergo PET/CT scans using these tracers and continue with their usual cancer treatments.

Participant Groups

Group I: 1/Baseline and Post-treatment Imaging Experimental Treatment 4 Interventions

18F-DCFPyL PET/CT imaging, CT and/or MRI and standard of care local ablative treatment

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 20 patients suspected of having pancreatic cancer, spiral CT detected 8 malignant lesions while MRI detected 7, indicating that both imaging techniques are effective but have slight differences in detection rates.

MRI enhanced with mangafodipir trisodium (Mn-DPDP) improved the clarity of pancreatic lesions, suggesting it may enhance diagnostic confidence and potentially improve detection and staging accuracy, although further research with a larger patient group is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI with mangafodipir trisodium in the detection of pancreatic tumours: comparison with helical CT. Rieber, A., Tomczak, R., Nüssle, K., et al.[2016]

MRI using mangafodipir trisodium (MnDPDP) detected 98 liver lesions, including two more than computed tomography (CT), demonstrating its superior sensitivity for identifying liver metastases in patients undergoing chemotherapy for colorectal cancer.

Both imaging techniques provided good quality results, but the enhanced MRI with MnDPDP showed a significant advantage over unenhanced MRI and CT, making it a valuable tool for monitoring liver lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Detection of liver metastases in colorectal cancer on chemotherapy. Comparative study between MRI with teslascan and computed tomography with intravenous contrast media]. Beziat, C., Pilleul, F., Yzebe, D., et al.[2019]

In a study involving 46 patients with 96 hepatocellular carcinomas, gadopentetate dimeglumine-enhanced MRI demonstrated superior diagnostic accuracy and sensitivity compared to Mn-DPDP-enhanced MRI, with a sensitivity of 87.5% versus 72.4%.

The false-negative rate for Mn-DPDP was significantly higher (27.6%) than for gadopentetate dimeglumine (12.5%), particularly for small lesions under 2 cm, indicating that gadopentetate dimeglumine is more effective for detecting smaller tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI for detection of hepatocellular carcinoma: comparison of mangafodipir trisodium and gadopentetate dimeglumine contrast agents. Youk, JH., Lee, JM., Kim, CS.[2015]

In a study involving 145 patients, Mn-DPDP-enhanced magnetic resonance imaging (MRI) correctly classified focal liver lesions in 74% of cases, significantly outperforming dual-phase spiral computed tomography (CT), which only achieved 57% accuracy (P = 0.001).

Enhanced MRI also excelled in distinguishing between malignant and benign lesions (85% accuracy) and identifying hepatocellular versus nonhepatocellular lesions (90% accuracy), compared to 68% and 64% for dual-phase CT, respectively, indicating its superior diagnostic capability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of liver lesions with mangafodipir trisodium-enhanced MR imaging: multicenter study comparing MR and dual-phase spiral CT. Oudkerk, M., Torres, CG., Song, B., et al.[2015]

In a study of 404 patients, contrast-enhanced MRI using mangafodipir trisodium (MnDPDP) significantly improved the detection and characterization of hepatic masses compared to unenhanced MRI and enhanced CT, leading to better diagnostic accuracy.

The use of MnDPDP-enhanced MRI provided additional diagnostic information in 48% of patients, resulting in changes to patient management in 6% of cases, highlighting its potential impact on clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. Multicenter phase III clinical trials. Efficacy of early imaging. Federle, M., Chezmar, J., Rubin, DL., et al.[2019]

Combining F-18 FDG and C-choline PET/CT significantly improves the diagnostic sensitivity for hepatocellular carcinoma (HCC), increasing detection rates from 63.1% to 89.5% in a study of 76 patients.

While F-18 FDG scans were positive in 61.1% of patients, the C-choline scan was able to detect HCC in 71.4% of those with initially negative F-18 FDG results, highlighting its effectiveness in identifying well-differentiated tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

F-18 FDG in conjunction with 11C-choline PET/CT in the diagnosis of hepatocellular carcinoma. Wu, HB., Wang, QS., Li, BY., et al.[2016]

In a study involving 39 patients with known or suspected hepatocellular carcinoma (HCC), the hepatocyte-specific PET tracer FDGal demonstrated a 100% specificity in identifying HCC, correctly detecting the disease in 22 out of 23 patients before treatment.

FDGal PET/CT not only confirmed HCC in patients where conventional imaging was inconclusive but also identified extrahepatic disease in nine patients, highlighting its potential as a valuable diagnostic tool for both intra- and extrahepatic HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential use of 2-[¹⁸F]fluoro-2-deoxy-D-galactose as a PET/CT tracer for detection of hepatocellular carcinoma. Sørensen, M., Frisch, K., Bender, D., et al.[2021]

The pilot study demonstrated that [18F]FSPG PET/CT has a 75% detection rate for hepatocellular carcinoma (HCC), outperforming standard imaging techniques in identifying tumors, especially those lacking typical MRI enhancement patterns.

In a comparison with [11C]acetate PET/CT, [18F]FSPG PET/CT showed significantly higher tumor-to-liver background ratios, suggesting it may provide better imaging quality and insights into HCC tumor metabolism, warranting further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of [18F]FSPG PET to Image Hepatocellular Carcinoma: First Clinical Evaluation in a US Population. Kavanaugh, G., Williams, J., Morris, AS., et al.[2019]

In a study involving 30 patients with colorectal cancer liver metastases, Primovist-enhanced MRI (P-MRI) demonstrated superior sensitivity (96%) and positive predictive value (PPV of 0.91) compared to MDCT and PET/CT, making it a more effective imaging modality for detecting liver lesions.

P-MRI was able to identify more lesions than both MDCT and PET/CT, suggesting it provides significant added value in the pre-surgical assessment of patients eligible for liver resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of MDCT, PET/CT and gadoxetic acid (Primovist(®))-enhanced MRI in patients with colorectal liver metastases being considered for hepatic resection: initial experience in a single centre. Chan, VO., Das, JP., Gerstenmaier, JF., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

MRI with mangafodipir trisodium in the detection of pancreatic tumours: comparison with helical CT. [2016]

2. France pubmed.ncbi.nlm.nih.gov

[Detection of liver metastases in colorectal cancer on chemotherapy. Comparative study between MRI with teslascan and computed tomography with intravenous contrast media]. [2019]

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

MRI for detection of hepatocellular carcinoma: comparison of mangafodipir trisodium and gadopentetate dimeglumine contrast agents. [2015]

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

Characterization of liver lesions with mangafodipir trisodium-enhanced MR imaging: multicenter study comparing MR and dual-phase spiral CT. [2015]

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

Efficacy and safety of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. Multicenter phase III clinical trials. Efficacy of early imaging. [2019]

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

F-18 FDG in conjunction with 11C-choline PET/CT in the diagnosis of hepatocellular carcinoma. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

The potential use of 2-[¹⁸F]fluoro-2-deoxy-D-galactose as a PET/CT tracer for detection of hepatocellular carcinoma. [2021]

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

Utility of [18F]FSPG PET to Image Hepatocellular Carcinoma: First Clinical Evaluation in a US Population. [2019]

9. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic performance of MDCT, PET/CT and gadoxetic acid (Primovist(®))-enhanced MRI in patients with colorectal liver metastases being considered for hepatic resection: initial experience in a single centre. [2021]