CT Scans for Pancreatic and Liver Cancer

Overseen by Eugene J. Koay

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

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

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies how well computed tomography works in diagnosing patients with pancreatic or hepatobiliary cancer. Computed tomography may help researchers predict how patients with pancreatic or hepatobiliary cancer may respond to chemotherapy.

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 data supports the effectiveness of the treatment CT Scans for Pancreatic and Liver Cancer?

Research suggests that CT scans can help identify larger lymph nodes, which may indicate cancer spread in pancreatic cancer. This can guide treatment decisions, such as whether to perform more extensive surgery or use additional therapies. ^{1 2 3 4 5}

Is CT-guided biopsy safe for humans?

CT-guided biopsies are generally safe, but there are some risks, especially for people with certain conditions like liver cirrhosis or hypervascular tumors. The procedure involves exposure to radiation, but studies are looking at ways to minimize this risk. ^{6 7 8 9 10}

How does this treatment differ from other treatments for pancreatic and liver cancer?

This treatment involves using CT scans to guide biopsies, which is unique because it allows for precise targeting of tumors in the pancreas and liver, potentially improving diagnosis and treatment planning compared to traditional methods. ^{7 11 12 13 14}

Research Team

Eugene J. Koay

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Computed Tomography (CT) (Imaging)

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.

Participant Groups

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+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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 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]

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]

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]

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]

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 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]

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]

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]

References

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

Intraoperative paraaortic lymph node sampling during resection for pancreatic cancer: evolving role in the modern chemotherapy era. [2023]

2. Spain pubmed.ncbi.nlm.nih.gov

Initial experience in sentinel lymph node detection in pancreatic cancer. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Lymph node size and metastatic infiltration in adenocarcinoma of the pancreatic head. [2010]

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

A preoperative scoring system to predict lymph node metastasis in intrahepatic cholangiocarcinoma. [2023]

5. Greece pubmed.ncbi.nlm.nih.gov

Detection of Lymph Nodes Metastasis in Biliary Carcinomas: Morphological Criteria by MDCT and the Clinical Impact of DWI-MRI. [2016]

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

Computed Tomography-Guided Biopsy for Small (≤20 mm) Lung Nodules: A Meta-Analysis. [2021]

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

Percutaneous transgastric computed tomography-guided biopsy of the pancreas using large needles. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events of Different Endoscopic Ultrasound-Guided Tissue Acquisition Methods: A Single-Center Retrospective Analysis. [2022]

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

Personnel exposure rates during simulated biopsies with a real-time CT scanner. [2004]

10. England pubmed.ncbi.nlm.nih.gov

Low-dose versus standard-dose computed tomography-guided biopsy for pulmonary nodules: a randomized controlled trial. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Diagnostic laparoscopy improves staging of pancreatic cancer deemed locally unresectable by computed tomography. [2019]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Computerized tomography of the mechanical jaundice in the involvement of the distal region of the common bile duct]. [2016]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Computed tomography in the diagnosis of mechanic jaundice complicated with diseases of the distal common bile duct]. [2016]

14. Japan 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. [2021]