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Pheochromocytoma, MetastaticNCT06015061

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

An observational study of Pheochromocytoma, Metastatic and Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Contrast-enhanced ultrasound(CEUS)
How many people
20 participants
Where
1 siteChina
Study dates
1 Mar 2023to 1 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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.
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  • 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%).

Who cannot join

  • 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.).
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  • 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.

Trial locations and contacts

1 site in 1 country.

Anli Tong contact

13911413589

tonganli@hotmail.com

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing

    Anli Tong, 13911413589, tonganli@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: Prediction and Evaluation of Anlotinib Treatment Response Using Contrast Enhanced Ultrasound in Patients With Pheochromocytoma or Paraganglioma

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.

Being tested
Contrast-enhanced ultrasound(CEUS)
Medical subject headings
Pheochromocytoma, Neoplasm Metastasis, Paraganglioma, Extra-Adrenal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contrast-enhanced ultrasound(CEUS)Diagnostic test

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

Study groups in NCT06015061
Study groupRoleWhat they receive
Pheochromocytoma or Paraganglioma Patients with Anlotinib Treatmentto evaluate the efficiency of contrast enhanced ultrasound in assessing effectiveness of anlotinib in patients with locally advanced, metastatic, or unresectable pheochromocytoma or paraganglioma(PPGL).
Receives: Diagnostic Test: Contrast-enhanced ultrasound(CEUS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2023
  2. Study start1 Mar 2023
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06015061
Sponsor's protocol ID
06086-04
Status last verified
Mar 2023
First submitted
22 May 2023
Last updated
29 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Pheochromocytoma, Metastatic and Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anli Tong (13911413589, tonganli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Baseline and after 1-2 cycles(each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06015061, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.

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