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Status unknownNCT06015061Updated Aug 29, 2023

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

An observational study in Pheochromocytoma, Metastatic, Ultrasonography and Paraganglioma, Malignant, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-29.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

Read the detailed description

Contrast-enhanced ultrasound (CEUS) is a non-invasive and efficient imaging technique which can observe the blood flow at the tissue perfusion level with microbubble contrast agents and obtain information about tumor perfusion. There have been several studies demonstrating the utility of CEUS for early prediction of response to neoadjuvant chemotherapy in breast cancer, pancrearic cancer as well as lymphoma. However, few studies have reported the use of CEUS for the evaluation of therapeutic response in PPGL. What quantitative parameters of CEUS can early reflect the neovascular changes after treatment with anlotinib in patients with locally advanced, metastatic, or unresectable PPGL? The aim of our study is to evaluate the parameters for CEUS imaging and the therapeutic response of PPGL before and after anlotinib therapy and to determine the most useful CEUS response parameters.

02

Conditions studied

  • Pheochromocytoma, Metastatic
  • Ultrasonography
  • Paraganglioma, Malignant
  • Pheochromocytoma Malignant
03

In context

Pheochromocytoma

151 studies on the registry are indexed under Pheochromocytoma; 56 are open to participants now.

This study's planned enrollment of 20 is below the median of 171 across 55 observational studies indexed under Pheochromocytoma.

Browse Pheochromocytoma studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 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%).

Exclusion criteria

Exclusion Criteria:

  • 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);
    • Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein content is confirmed to be greater than 1.0 g;
    • Patients who have seizures and need treatment;
  • Any of the following conditions =\< 6 months prior to registration: Cerebrovascular accident (CVA) or transient ischemic attack (TIA); Serious or unstable cardiac arrhythmia; Pulmonary embolism, untreated deep venous thrombosis (DVT).

Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment.

  • Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders.
  • Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
  • Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before enrollment, patients with any bleeding or bleeding event ≥ CTCAE grade 3, unhealed wounds, ulcers or fractures.
  • Patients are using drugs that interact with Anlotinib.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testContrast-enhanced ultrasound(CEUS)

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29962874 ↗
  • 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. PubMed 31985457 ↗
  • 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. PubMed 29138385 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06015061
Responsible party
Sponsor
First posted
Aug 29, 2023
Start date
Mar 1, 2023
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Aug 29, 2023

Study contacts

Anli Tong
Contact
tonganli@hotmail.com
13911413589
Anli Tong
principal investigator · Peking Union Medical College Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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