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
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).
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.
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.
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in patients with locally advanced, metastatic, or unresectable pheochromocytoma or paraganglioma.
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Laboratory requirements:
Exclusion Criteria:
Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.).
Active or uncontrolled intercurrent illness including, but not limited to
Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment.
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)
CEUS is a quantitative kinetic imaging modality that can assess intravascular blood flow in PPGL tumors.
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)
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)
Plan to share: No
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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