CT Scans for Pancreatic and Liver Cancer

Overseen By Eugene Koay

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Distant metastasis, Resectable tumors, Congestive heart failure, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6-12 weeks

259 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well CT scans help doctors understand and predict responses to chemotherapy in patients with pancreatic or hepatobiliary (liver-related) cancers. Participants will undergo two CT scans as part of their regular cancer care: one before starting chemotherapy and another during their first follow-up visit with their oncologist. Individuals diagnosed with pancreatic or hepatobiliary cancer, set to receive chemotherapy, and with non-distant metastatic cancer (cancer that hasn't spread to distant parts of the body) may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to advance cancer care by enhancing the understanding of treatment responses.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that computed tomography is safe for diagnosing pancreatic or hepatobiliary cancer?

Research has shown that CT scans often detect pancreatic and liver cancers. They provide clear images of the pancreas and help doctors determine if the cancer has spread. Patients usually tolerate these scans well, and they are a regular part of medical care for many health issues. Most people experience no side effects from CT scans. However, a few might react to the contrast dye used in some scans, though this is rare. Overall, CT scans are considered safe for diagnosing cancer and assessing treatment effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of using CT scans to better manage pancreatic and liver cancer treatment. Unlike traditional approaches that rely solely on chemotherapy and surgery, this method incorporates strategic imaging to assess the cancer's response to treatment. By performing a CT scan before starting chemotherapy and another at the first restaging visit, doctors can gain valuable insights into how well the treatment is working and adjust plans accordingly. This approach aims to personalize and potentially improve the effectiveness of cancer care for patients.

What evidence suggests that computed tomography is effective for diagnosing pancreatic or hepatobiliary cancer?

Research has shown that CT scans have become more accurate in evaluating pancreatic tumors, increasing the ability to determine if a tumor can be surgically removed from 73% to 83%. This improvement helps doctors better understand the size and spread of cancer in the pancreas. Although other imaging methods like MRI may be more sensitive in certain situations, CT scans remain crucial for diagnosing pancreatic and liver cancers. In this trial, participants will receive CT scans as part of their regular cancer care. These scans can help doctors predict patient responses to chemotherapy by revealing changes in the cancer over time, making them a valuable component of cancer care. ^{2 4 6 7 8}

Who Is on the Research Team?

Eugene J. Koay

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with non-metastatic pancreatic cancer or hepatobiliary cancer (like liver cancer) who are fit enough for chemotherapy. They must have had or be planned to have CT/MRI scans and agree to use contraception if of childbearing potential. Exclusions include pregnant women, those with serious heart conditions, active infections, other cancers, or any condition that prevents following the study protocol.

Inclusion Criteria

My liver cancer involves one or more tumors.

My pancreatic cancer has not spread far and cannot be removed by surgery or might be difficult to remove.

I have pancreatic cancer and can carry out all my daily activities without help.

Exclusion Criteria

I do not have a current fever or acute infection, but chronic conditions like hepatitis are okay.

I have a health condition that prevents me from undergoing chemotherapy, radiotherapy, or CT scans with iodine contrast.

I have another active cancer besides non-melanoma skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo a baseline CT scan before the start of chemotherapy

1 week

1 visit (in-person)

Treatment

Participants receive chemotherapy and undergo CT scans after 4 to 6 cycles of fluorouracil/irinotecan/leucovorin calcium/oxaliplatin, or after 4 infusions of gemcitabine/nab-paclitaxel, or 6 to 12 weeks after radiotherapy

6-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up CT scans and completion of the MD Anderson Symptom Inventory for Gastrointestinal cancer questionnaire

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography (CT)

Trial Overview

The trial is testing how well computed tomography (CT) can diagnose and predict treatment responses in patients with pancreatic or hepatobiliary cancers. It involves getting a CT scan and filling out questionnaires to help researchers understand the effectiveness of CT in guiding chemotherapy decisions.

How Is the Trial Designed?

Group I: Computed Tomography Scans (CT) Experimental Treatment 2 Interventions

Participants to receive 2 computed tomography (CT) scans that are part of their regular cancer care. One (1) scan performed before the start of chemotherapy, and the other at first restaging visit with oncologist. Participant to complete the MD Anderson Symptom Inventory for Gastrointestinal cancer (MDASI-GI) questionnaire at baseline visit, and follow up visit.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

CT scans are effective for diagnosing conditions related to jaundice, with a sensitivity of 78.8% and specificity of 91.3% for pancreatic head cancer, and 84.6% sensitivity and 96.7% specificity for choledocholithiasis.

CT imaging helps determine the cause of jaundice and assess the extent of biliary tract involvement, aiding in the differentiation between mechanical and parenchymatous jaundices, which is crucial for planning surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Computerized tomography of the mechanical jaundice in the involvement of the distal region of the common bile duct]. Todua, FI., Karmazanovskiĭ, GG., Vikhorev, AV.[2016]

In a study of 34 patients undergoing CT-guided biopsies for pancreatic tumors, a transgastric approach using large needles successfully obtained tumor tissues in all cases without major complications.

The procedure demonstrated safety, with only one case of transient pneumoperitoneum and no instances of hemorrhage or peritonitis, indicating that this method can be a viable alternative for pancreatic biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous transgastric computed tomography-guided biopsy of the pancreas using large needles. Tseng, HS., Chen, CY., Chan, WP., et al.[2021]

Ultrasound-guided percutaneous pancreatic biopsy is highly effective for diagnosing unresectable pancreatic cancer, with sensitivity and accuracy rates of 93% and 93% for core biopsies, and 86% and 86% for fine-needle aspiration biopsies, comparable to liver metastases biopsies.

The procedure has a complication rate of 21.4%, which is lower than the 38.7% complication rate for liver metastases biopsies, indicating it is a safer option for patients, especially considering the lower incidence of fever and infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided percutaneous pancreatic tumor biopsy in pancreatic cancer: a comparison with metastatic liver tumor biopsy, including sensitivity, specificity, and complications. Matsubara, J., Okusaka, T., Morizane, C., et al.[2021]

In a study of 192 patients undergoing endoscopic ultrasound-guided tissue acquisition (EUS-TA) for pancreatic lesions, hypervascular tumors and liver cirrhosis were identified as significant risk factors for adverse events, with odds ratios of 4.96 and 5.3, respectively.

The use of Franseen-tip needles did not increase the risk of adverse events compared to conventional FNA or FNB needles, suggesting that these newer needles are as safe as traditional options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events of Different Endoscopic Ultrasound-Guided Tissue Acquisition Methods: A Single-Center Retrospective Analysis. Lin, YC., Yen, HH., Huang, SP., et al.[2022]

In a study of 771 pancreatic cancer patients, 10% had confirmed metastasis in paraaortic lymph nodes (PALNs), which was linked to early recurrence and shorter survival rates after surgery, highlighting the importance of PALN sampling in treatment planning.

The impact of PALN metastasis on survival varied based on treatment strategy; patients undergoing neoadjuvant therapy showed similar outcomes regardless of PALN metastasis, suggesting that treatment approach should be tailored to individual cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative paraaortic lymph node sampling during resection for pancreatic cancer: evolving role in the modern chemotherapy era. Kazami, Y., Oba, A., Ono, Y., et al.[2023]

A new method for detecting sentinel lymph nodes (SLN) in pancreatic cancer patients using lymphoscintigraphy and gamma probe was found to be technically feasible in a study of 7 patients, although it presented challenges.

Out of the 7 patients, only 4 could undergo surgical resection due to advanced disease, and intraoperative SLN detection was successful in 2 patients, both of whom had negative results, indicating the need for further validation of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience in sentinel lymph node detection in pancreatic cancer. Beisani, M., Roca, I., Cardenas, R., et al.[2018]

In a study of 52 pancreatic cancer patients, 18% of lymph nodes were found to be metastatic, but many metastatic nodes were ≤5 mm in size, challenging the assumption that larger nodes are always malignant.

The findings indicate that lymph node size is not a reliable indicator of metastatic involvement in pancreatic cancer, suggesting that current imaging criteria may need to be reevaluated for better staging and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lymph node size and metastatic infiltration in adenocarcinoma of the pancreatic head. Prenzel, KL., Hölscher, AH., Vallböhmer, D., et al.[2010]

A new preoperative lymph node metastasis (LNM) scoring system, developed from MRI and clinical findings, effectively predicts lymph node metastasis in patients with intrahepatic cholangiocarcinoma (iCCA), based on a study of 273 patients across three cohorts.

This scoring system, which includes serum carcinoembryonic antigen levels and specific MRI findings, demonstrated better predictive accuracy for pathologic LNM compared to using MRI-suspicious lymph nodes alone, and it was also linked to overall survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preoperative scoring system to predict lymph node metastasis in intrahepatic cholangiocarcinoma. Rhee, H., Lim, HJ., Han, K., et al.[2023]

CT scans are effective for diagnosing conditions related to jaundice, with a sensitivity of 78.8% and specificity of 91.3% for pancreatic head cancer, and 84.6% sensitivity and 96.7% specificity for choledocholithiasis.

CT imaging can accurately differentiate between mechanical and parenchymatous jaundices and assess the resectability of malignant tumors, aiding in surgical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Computed tomography in the diagnosis of mechanic jaundice complicated with diseases of the distal common bile duct]. Todua, FI., Karmazanovskiĭ, GG., Vikhorev, AV.[2016]

In a study of 74 patients with locally unresectable pancreatic cancer, staging laparoscopy revealed hidden metastatic disease in 34% of cases, highlighting the limitations of CT scans in accurately detecting metastasis.

The study found that tumors located in the body and tail of the pancreas were more likely to have unsuspected metastasis compared to those in the head, with 53% of body/tail tumors showing occult disease versus 28% in head tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic laparoscopy improves staging of pancreatic cancer deemed locally unresectable by computed tomography. Liu, RC., Traverso, LW.[2019]

CT-guided biopsy for small lung nodules (≤20 mm) has a high technical success rate of 94% and a diagnostic accuracy of 90%, based on a meta-analysis of 25 studies involving 2922 biopsies.

The procedure is generally safe, with pneumothorax occurring in 19% of cases and hemoptysis in 12%, indicating manageable complication rates for this diagnostic method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed Tomography-Guided Biopsy for Small (≤20 mm) Lung Nodules: A Meta-Analysis. Liu, GS., Wang, SQ., Liu, HL., et al.[2021]

In a study of 18 patients with biliary carcinomas, multi-slice CT (MDCT) showed that lymph nodes (LNs) with a maximum diameter greater than 8 mm and a long/short axis (L/S) ratio of less than 2 had an accuracy of 81% for diagnosing metastasis.

Diffusion weighted MRI (DWI-MRI) demonstrated that metastatic LNs had significantly lower apparent diffusion coefficient (ADC) values compared to non-metastatic LNs, with a cut-off ADC value of 1.8 x10(-3) yielding a sensitivity of 75% and a positive predictive value of 82%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Lymph Nodes Metastasis in Biliary Carcinomas: Morphological Criteria by MDCT and the Clinical Impact of DWI-MRI. Morine, Y., Shimada, M., Imura, S., et al.[2016]

In a study involving 200 patients, low-dose CT-guided biopsy for pulmonary nodules significantly reduced radiation exposure compared to standard-dose CT, with mean dose-length products of 31.5 vs. 333.5 mGy-cm.

Both low-dose and standard-dose CT-guided biopsies demonstrated comparable diagnostic accuracy and safety, with no significant differences in diagnostic yield or complication rates, making low-dose CT a viable alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose versus standard-dose computed tomography-guided biopsy for pulmonary nodules: a randomized controlled trial. Li, EL., Ma, AL., Wang, T., et al.[2023]

The study measured radiation exposure to radiologists during CT-guided needle biopsies, finding that the average exposure was 123 mR to the fingers and significantly lower to other body areas, indicating manageable radiation levels during the procedure.

Positioning the operator at the head of the CT machine significantly reduced radiation exposure, suggesting that this technique can enhance safety for medical personnel during interventional procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personnel exposure rates during simulated biopsies with a real-time CT scanner. Mellenberg, DE., Sato, Y., Thompson, BH., et al.[2004]

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In this study, 51.9% of the patients who underwent CT before pancreatic cancer diagnosis had findings suggestive of pancreatic cancer in a retrospective review.

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Tests for Pancreatic Cancer | Diagnosing ...

CT scans are often used to diagnose pancreatic cancer because they can show the pancreas fairly clearly. They can also help show if cancer has spread.