Prediction and Evaluation of Anlotinib Treatment Response Using Contrast Enhanced Ultrasound PPGL Patients

NCT06015061 | Unknown

• 1 other identifier: 06086-04
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Anlotinib is a multi-target receptor tyrosine kinase inhibitor (TKI) targeting tumor angiogenesis and growth. The purpose of this study is to evaluate the efficiency of contrast enhanced ultrasound in assessing effectiveness of anlotinib in patients with locally advanced, metastatic, or unresectable pheochromocytoma or paraganglioma(PPGL).

Conditions

Pheochromocytoma, Metastatic; Ultrasonography; Paraganglioma, Malignant; Pheochromocytoma Malignant

Outcome Measures

Primary Outcomes (2)

• Evaluate if tumor uptake of contrast agent is predictive of response to anlotinib therapy measured by comparison of Peak Intensity (PI) at CEUS imaging prior to and after therapy.

  Before initiation of the therapy and during anlotinib therapy, patients would receive CEUS examination. The dynamic CEUS images of each lesion were analysed with the aid of time intensity curves (TICs) drawn by QLAB software (Philips Healthcare, Andover, MA). PI measurements will be compared to clinical measurement of response to treatment taking into consideration standard response criteria including radiological imaging, biochemical (catecholamine levels) response.

  Baseline and after 1-2 cycles(each cycle is 21 days)

• Evaluate if the time to peak (TTP) is predictive of response to anlotinib therapy measured by comparison of TTP at CEUS imaging prior to and after therapy.

  Before initiation of the therapy and during anlotinib therapy, patients would receive CEUS examination. The dynamic CEUS images of each lesion were analysed with the aid of time intensity curves (TICs) drawn by QLAB software (Philips Healthcare, Andover, MA). TTP measurements will be compared to clinical measurement of response to treatment taking into consideration standard response criteria.

  Baseline and after 1-2 cycles(each cycle is 21days)

Study Arms (1)

Pheochromocytoma or Paraganglioma Patients with Anlotinib Treatment

to evaluate the efficiency of contrast enhanced ultrasound in assessing effectiveness of anlotinib in patients with locally advanced, metastatic, or unresectable pheochromocytoma or paraganglioma(PPGL).

Diagnostic Test: Contrast-enhanced ultrasound(CEUS)

Interventions

Contrast-enhanced ultrasound(CEUS) DIAGNOSTIC_TEST

CEUS is a quantitative kinetic imaging modality that can assess intravascular blood flow in PPGL tumors.

Pheochromocytoma or Paraganglioma Patients with Anlotinib Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

in patients with locally advanced, metastatic, or unresectable pheochromocytoma or paraganglioma.

You may qualify if:

• years of age or older.
• Provide written informed consent.
• Willing to return to enrolling institution for follow-up.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
• Life expectancy \> 3 months.
• Patients diagnosis with pheochromocytoma or paraganglioma will received anlotinib treatment.
• Laboratory requirements:
• Absolute granulocyte count (AGC) greater than 1.5 x 109/L;
• Platelet count greater than 80 x 109/L;
• Hemoglobin greater than 90g/L;
• Serum bilirubin less than 1.5 x upper limit of normal (ULN);
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN;
• Serum creatinine less than 1.5 x ULN or creatinine clearance (CCr)≥60ml/min;
• Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).

You may not qualify if:

• Patients who are allergic to ultrasound contrast agents.
• Any of the following:Pregnant women,Nursing women,Men or women of childbearing potential who are unwilling to employ adequate contraception.
• Patients who have previously used other anti-vascular targeted drugs, such as sunitinib, bevacizumab, endurance, etc.
• Chemotherapy/systemic therapy, radiotherapy, immunotherapy or surgery within 4 weeks prior to kinase inhibitor therapy.
• Patients with another primary malignancy within 5 years prior to starting study drug.
• Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.).
• Patients with known untreated brain metastases are excluded. Patients having a history of brain metastasis that have been previously irradiated or resected greater than 2 months prior to enrollment and are clinically and radiographically stable will be considered for enrollment. Patients with brain metastases with symptoms or symptom control for less than 2 months.
• Active or uncontrolled intercurrent illness including, but not limited to
• Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg);
• Patients with uncontrolled myocardial ischemia or myocardial infarction, arrhythmia (including QTC≥480ms), and uncontrolled congestive heart failure，grade ≥2（New York Heart Association )
• ongoing or active infection;
• Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment;
• Renal failure requires hemodialysis or peritoneal dialysis;
• Have a history of immunodeficiency, including HIV or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Diabetes is poorly controlled (fasting blood glucose (FBG)\> 10mmol/L);

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (3)

• Kim Y, Kim SH, Song BJ, Kang BJ, Yim KI, Lee A, Nam Y. Early Prediction of Response to Neoadjuvant Chemotherapy Using Dynamic Contrast-Enhanced MRI and Ultrasound in Breast Cancer. Korean J Radiol. 2018 Jul-Aug;19(4):682-691. doi: 10.3348/kjr.2018.19.4.682. Epub 2018 Jun 14.

  PMID: 29962874 RESULT

• Zhang Q, Wu L, Yang D, Qiu Y, Yu L, Dong Y, Wang WP. Clinical application of dynamic contrast enhanced ultrasound in monitoring the treatment response of chemoradiotherapy of pancreatic ductal adenocarcinoma. Clin Hemorheol Microcirc. 2020;75(3):325-334. doi: 10.3233/CH-190786.

  PMID: 31985457 RESULT

• Xin L, Yan Z, Zhang X, Zang Y, Ding Z, Xue H, Zhao C. Parameters for Contrast-Enhanced Ultrasound (CEUS) of Enlarged Superficial Lymph Nodes for the Evaluation of Therapeutic Response in Lymphoma: A Preliminary Study. Med Sci Monit. 2017 Nov 15;23:5430-5438. doi: 10.12659/msm.907293.

  PMID: 29138385 RESULT

MeSH Terms

Conditions

Pheochromocytoma; Neoplasm Metastasis; Paraganglioma, Extra-Adrenal

Condition Hierarchy (Ancestors)

Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anli Tong

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anli Tong

CONTACT

13911413589; tonganli@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: August 29, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)