PET/CT vs. Cardiac CT for Coronary Artery Disease

(PET; CT Trial)

Overseen By Tia Thomas, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Coronary heart disease, Pregnancy, Atrial fibrillation, Morbid obesity, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

33 Participants Needed

Trial Summary

What is the purpose of this trial?

Early detection of coronary atherosclerotic disease facilitates adequate prevention. The purpose of this study is to compare an assessment of coronary atherosclerotic disease burden by positron emission tomography / computed tomography (NaF-PET/CT) with those of conventional and ultra-high-resolution-CT (UHR-CT) in patients with suspected coronary artery disease. For this purpose, the investigators plan to include 33 patients with symptoms concerning for CAD who have been referred for cardiac CT testing.

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 PET/CT, Yttrium-90 Radioembolization, Selective Internal Radiation Therapy (SIRT), Y-90 SIRT for coronary artery disease?

While there is no direct evidence for coronary artery disease, Yttrium-90 radioembolization (a type of SIRT) has shown effectiveness in treating liver cancers and metastases by improving clinical outcomes and facilitating surgical options in some cases. ^{1 2 3 4 5}

Is Yttrium-90 Radioembolization (SIRT) safe for humans?

Yttrium-90 Radioembolization, also known as Selective Internal Radiation Therapy (SIRT), has been used safely for treating liver tumors for over two decades. It is considered a promising and minimally invasive treatment, though it can have complications if not properly managed. ^{1 6 7 8 9}

How does the PET/CT treatment for coronary artery disease differ from other treatments?

The PET/CT treatment for coronary artery disease is unique because it involves Yttrium-90 Radioembolization, which is a form of selective internal radiation therapy (SIRT) that delivers targeted radiation directly to the affected area, potentially reducing damage to surrounding tissues compared to traditional radiation therapy. ^{10 11 12 13 14}

Research Team

Armin A Zadeh, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for men and women over 18 who have stable symptoms suggesting coronary artery disease (CAD) and are referred for a coronary CT angiography. It's not suitable for pregnant individuals, those with severe obesity (BMI >40), a history of heart disease, atrial fibrillation, or any condition that could affect their participation as per the investigator.

Inclusion Criteria

I am referred for a heart scan due to stable heart disease symptoms.

Exclusion Criteria

I have had a heart attack or surgery to improve blood flow to my heart.

Pregnancy

Any other clinically significant medical condition that in the opinion of the Investigator could impact the patient's ability to successfully complete the trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants undergo both NaF-PET/CT and conventional cardiac CT to assess coronary atherosclerotic disease

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic testing

60 days

Treatment Details

Interventions

• PET/CT

Trial Overview The study compares two imaging methods to detect coronary atherosclerotic disease: PET/CT versus conventional and ultra-high-resolution cardiac CT. The goal is to determine which method better identifies CAD in patients showing symptoms suggestive of this condition.

Participant Groups

Group I: Main group Experimental Treatment 1 Intervention

All patients undergo both, experimental and standard, tests

PET/CT is already approved in European Union, United States for the following indications:

Approved in European Union as Y-90 SIRT for:

• Hepatocellular carcinoma (HCC)
• Liver metastasis of colorectal cancer (mCRC)
• Intrahepatic cholangiocarcinoma (ICC)
• Liver metastasis of neuroendocrine tumors (NETs)
• Liver metastasis of breast cancer
• Liver metastasis of uveal melanoma

Approved in United States as Y-90 SIRT for:

• Hepatocellular carcinoma (HCC)
• Liver metastasis of colorectal cancer (mCRC)
• Intrahepatic cholangiocarcinoma (ICC)
• Liver metastasis of neuroendocrine tumors (NETs)
• Liver metastasis of breast cancer
• Liver metastasis of uveal melanoma

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

Selective internal radiotherapy (SIRT) with yttrium-90 can lead to significant tumor response in patients with hepatic malignancies, allowing for subsequent liver resection in selected cases, as demonstrated by a mean lesion volume reduction of 475 cm³ in 12 patients.

While SIRT is generally safe with no complications noted post-treatment, the study found a 67% morbidity rate and 11% mortality rate within 90 days after surgery, highlighting the need for careful patient selection and further research to optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver Resection After Selective Internal Radiation Therapy with Yttrium-90: Safety and Outcomes. Mafeld, S., Littler, P., Hayhurst, H., et al.[2020]

Y-90 radioembolization is an effective salvage therapy for patients with unresectable liver metastases, with a median hepatic progression-free survival of 4.4 months and median overall survival of 10.1 months based on a study of 78 patients.

The study identified that lower international normalized ratio (INR) levels are a significant predictor of better hepatic progression-free survival, highlighting the importance of liver function in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 radioembolization in patients with unresectable liver metastases: determining the factors that lead to treatment efficacy. Gunduz, S., Ozgur, O., Bozcuk, H., et al.[2014]

Selective internal radiotherapy (SIRT) using yttrium-90 microspheres can enhance clinical outcomes for patients with inoperable liver cancer by targeting tumors while protecting healthy tissue.

Effective planning for SIRT is crucial to avoid serious side effects like radiation-induced liver disease, and it is recommended to use multiple planning methods to determine the appropriate microsphere activity for each patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. Lau, WY., Kennedy, AS., Kim, YH., et al.[2022]

In a study involving 10 selective internal radiation therapy (SIRT) procedures for patients with unresectable hepatocellular carcinoma, the scaled 99mTc/90Y SPECT/CT method provided tumor absorbed dose estimates that were closer to the gold standard 90Y PET/CT, with an average deviation of only -2 ± 18%.

The 90Y bremsstrahlung SPECT/CT method showed a much larger average deviation of -50 ± 13% from the 90Y PET/CT values, indicating that the choice of imaging method significantly impacts the accuracy of tumor dosimetry in 90Y SIRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D image-based dosimetry for Yttrium-90 radioembolization of hepatocellular carcinoma: Impact of imaging method on absorbed dose estimates. Brosch, J., Gosewisch, A., Kaiser, L., et al.[2021]

In a study of 68 patients with colorectal liver metastases, those who received selective internal radiotherapy (SIRT) after first-line chemotherapy had a significantly longer median progression-free survival of 9 months compared to just 3 months for those who received SIRT after two or more lines of chemotherapy.

SIRT was found to be safe, with no grade 3 or higher adverse events reported, indicating that it is a valid treatment option for patients with colorectal liver metastases, especially when used earlier in the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of Selective Internal Radiotherapy With Yttrium-90 as Consolidation Treatment After Chemotherapy in Metastatic Colorectal Cancer. Cortesi, E., Caponnetto, S., Masi, G., et al.[2021]

Selective internal yttrium-90 radioembolization therapy ((90)Y-SIRT) is an effective and safe minimally invasive treatment for liver malignant tumors, supported by clinical applications over the past two decades and recognized by major cancer treatment guidelines.

A consensus was formed by experts from various medical fields to standardize the management and treatment procedures for (90)Y-SIRT, addressing critical aspects such as indications, contraindications, postoperative follow-up, and radiation safety, to enhance treatment safety and success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chinese expert consensus on selective internal radiation therapy with yttrium-90 for primary and metastatic hepatocellular carcinoma]. [2021]

In a study of 825 patients with liver malignancies, most extrahepatic shunts causing complications during Selective Internal Radiation Therapy (SIRT) with Y-90 were identified using hepatic digital subtraction angiography (DSA).

However, SPECT/CT imaging revealed additional shunts in 6.5% of patients, leading to further interventions and preventing SIRT in some cases, highlighting the importance of combining imaging techniques for better patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioembolization with Y-90 Glass Microspheres: Do We Really Need SPECT-CT to Identify Extrahepatic Shunts? Theysohn, JM., Ruhlmann, M., Müller, S., et al.[2018]

A new composite of 99mTc-labeled carbon nanoparticles attached to polymer microspheres can be imaged using standard SPECT, providing a better method for dosimetry in selective internal radiation therapy (SIRT) for liver tumors.

These radiolabeled microspheres showed high retention in both normal and tumor-implanted rabbit livers, with preferential uptake in tumor sites due to increased blood flow, indicating their potential as effective imaging tools for monitoring treatment distribution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

99mTc-radiolabeled composites enabling in vivo imaging of arterial dispersal and retention of microspheres in the vascular network of rabbit lungs, liver, and liver tumors. Stephens, RW., Tredwell, GD., Knox, KJ., et al.[2022]

Selective internal radiotherapy (SIRT) using yttrium-90 (Y90) is effective for treating unresectable liver tumors, but it can unintentionally irradiate the gallbladder, leading to complications.

In a study of 295 patients, strategies like occluding the cystic artery or altering catheter positions significantly reduced the risk of gallbladder irradiation, with only one case of cholecystitis observed, which was successfully treated without the need for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective internal radiotherapy (SIRT) of hepatic tumors: how to deal with the cystic artery. Theysohn, JM., Müller, S., Schlaak, JF., et al.[2016]

In a study of 828 breast cancer patients treated with radiation therapy, the observed rates of cardiac events were significantly lower than expected, with a standardized incidence ratio of myocardial infarction (MI) at 0.44, indicating a reduced risk of heart issues post-treatment.

Despite the overall lower risk, patients who received radiation to the left side of the chest showed a statistically significant increased risk of MI, highlighting the need for improved techniques to minimize long-term cardiac risks in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of myocardial infarction and coronary artery disease and risk factors in patients treated with radiation therapy for early-stage breast cancer. Jagsi, R., Griffith, KA., Koelling, T., et al.[2007]

Intravascular brachytherapy (IVBT) using the beta-emitting source (90)Sr/(90)Y is an effective method for treating coronary artery stenosis, a common cardiac disease associated with restenosis.

Monte Carlo simulations showed that the dosimetry parameters and effective equivalent doses to the heart and surrounding tissues during IVBT were consistent with published experimental data, indicating the safety and reliability of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absorbed dose assessment of cardiac and other tissues around the cardiovascular system in brachytherapy with 90Sr/90Y source by Monte Carlo simulation. Saghamanesh, S., Karimian, A., Abdi, M.[2011]

In a study of 20 asymptomatic breast cancer patients who received radiation therapy (RT) at least 5 years prior, no significant occult atherosclerosis was detected in the coronary arteries or aorta using Multidetector Computed Tomography (MDCT).

This finding contrasts with earlier studies that suggested increased cardiovascular risks associated with RT, indicating that long-term cardiac health may not be as adversely affected as previously thought in patients treated with RT for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary Calcium Scanning in Patients after Adjuvant Radiation for Early Breast Cancer and Ductal Carcinoma In situ. Chang, M., Suh, J., Kirtani, V., et al.[2021]

In a study of 204 breast cancer patients who developed coronary artery disease (CAD) after radiation therapy, the median follow-up was 7.3 years, showing that while CAD occurred more frequently in areas of the heart receiving higher radiation doses, no significant risk of CAD was found overall at this follow-up duration.

The study revealed that the highest radiation doses were delivered to specific cardiac structures, particularly the left ventricle and left anterior descending coronary artery for left-sided radiation, but there were no significant differences in CAD occurrence between patients treated on the left versus the right side.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation dose to heart and cardiac substructures and risk of coronary artery disease in early breast cancer patients: A DBCG study based on modern radiation therapy techniques. Holm Milo, ML., Slot Møller, D., Bisballe Nyeng, T., et al.[2023]

Cardiac SPECT imaging reveals that radiation therapy (RT) for left breast or chest wall cancer can lead to early perfusion defects in the heart, particularly in the apical and anterolateral regions of the left ventricle.

The risk of these perfusion defects is closely related to the volume of the left ventricle that receives radiation, highlighting the importance of using techniques to minimize heart exposure during RT to prevent cardiac abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early cardiac perfusion defects after left-sided radiation therapy for breast cancer: is there a volume response? Kaidar-Person, O., Zagar, TM., Oldan, JD., et al.[2018]

References

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

Liver Resection After Selective Internal Radiation Therapy with Yttrium-90: Safety and Outcomes. [2020]

2. Greece pubmed.ncbi.nlm.nih.gov

Yttrium-90 radioembolization in patients with unresectable liver metastases: determining the factors that lead to treatment efficacy. [2014]

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

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

3D image-based dosimetry for Yttrium-90 radioembolization of hepatocellular carcinoma: Impact of imaging method on absorbed dose estimates. [2021]

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

Efficacy and Tolerability of Selective Internal Radiotherapy With Yttrium-90 as Consolidation Treatment After Chemotherapy in Metastatic Colorectal Cancer. [2021]

6. China pubmed.ncbi.nlm.nih.gov

[Chinese expert consensus on selective internal radiation therapy with yttrium-90 for primary and metastatic hepatocellular carcinoma]. [2021]

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

Radioembolization with Y-90 Glass Microspheres: Do We Really Need SPECT-CT to Identify Extrahepatic Shunts? [2018]

8. New Zealand pubmed.ncbi.nlm.nih.gov

99mTc-radiolabeled composites enabling in vivo imaging of arterial dispersal and retention of microspheres in the vascular network of rabbit lungs, liver, and liver tumors. [2022]

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

Selective internal radiotherapy (SIRT) of hepatic tumors: how to deal with the cystic artery. [2016]

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

Rates of myocardial infarction and coronary artery disease and risk factors in patients treated with radiation therapy for early-stage breast cancer. [2007]

11. England pubmed.ncbi.nlm.nih.gov

Absorbed dose assessment of cardiac and other tissues around the cardiovascular system in brachytherapy with 90Sr/90Y source by Monte Carlo simulation. [2011]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Coronary Calcium Scanning in Patients after Adjuvant Radiation for Early Breast Cancer and Ductal Carcinoma In situ. [2021]

13. Ireland pubmed.ncbi.nlm.nih.gov

Radiation dose to heart and cardiac substructures and risk of coronary artery disease in early breast cancer patients: A DBCG study based on modern radiation therapy techniques. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Early cardiac perfusion defects after left-sided radiation therapy for breast cancer: is there a volume response? [2018]