Ovary CancerNCT06556342
The Efficacy and Safety of FRD001 in Ultrasound Contrast Imaging for Malignant Ovarian Masses in Women
A study testing FRD001 in people with Ovary Cancer, run by Tongji Hospital at 1 site in China.
Trial summary
This is a Prospective, Self-Controlled, Open-Label, Multicenter Clinical Trial. The purpose of this study is to demonstrate the efficacy and safety of FRD001 injection in ultrasound contrast imaging for the differentiation between benign and malignant ovarian masses in women, using gray-scale and power Doppler… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovary Cancer
- What is being tested?
- FRD001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants must meet the following inclusion criteria to be eligible for enrollment in this study:
- Female participants aged 18 to 75 years (inclusive of the age limits);
- Patients with untreated unilateral or bilateral, unilocular or multilocular cystic/solid masses;
- Expected survival of at least 3 months;
- ECOG performance status of 0 to 2 for participants with malignant tumors;
- Organ function levels must meet the following requirements: a. Hematology: WBC ≥ 3 × 10^9/L, ANC ≥ 1.5 × 10^9/L, Hb ≥ 90 g/L, PLT ≥ 75 × 10^9/L; b. Liver function: TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN (≤ 5 × ULN for patients with liver metastases); c. Kidney function: Cr ≤ 1.5 × ULN; d. Coagulation function: Prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, International normalized ratio (INR) ≤ 1.5 × ULN; e. Electrolytes: Corrected magnesium ≥ LLN, with allowance for correction of electrolytes during screening; f. Cardiac function: Left ventricular ejection fraction ≥ 50%; g. Pulse oximetry ≥ 93%;
- Women of childbearing potential must use effective contraception during the study (effective contraceptive methods include sterilization, intrauterine hormonal devices, condoms, contraceptive pills/devices, abstinence, or vasectomy);
- Participants must fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily agree to participate, and sign a written informed consent form, demonstrating the ability to adhere to the protocol requirements to complete the study.
Who cannot join
- Participants who meet any of the following criteria are not eligible for enrollment:
- Patients with benign teratomas;
- Patients who have undergone total removal of the uterine appendages;
- Patients with congenital malformations of the reproductive system;
- Patients who have received radiotherapy, chemotherapy, or invasive procedures (including but not limited to radiofrequency ablation) during the administration of the investigational medicinal product (IMP) and the confirmatory diagnostic examination;
- Women planning to become pregnant within 6 months, currently pregnant, or breastfeeding, or women of childbearing potential with a positive pregnancy test during the screening period;
Show all 21Show fewer
- Individuals allergic to the components of FRD001 injection or with a history of other severe allergies;
- Insufficient acoustic window indicated by ultrasound examination during screening or prior examinations;
- Presence of contraindications for imaging examinations related to the study protocol;
- Conditions such as adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or pulmonary embolism;
- Severe cardiovascular or cerebrovascular diseases, including but not limited to: a. Significant cardiac rhythm or conduction abnormalities that require clinical intervention, such as ventricular arrhythmias, second- to third-degree atrioventricular block, or QTc interval ≥ 450 ms; b. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other cardiovascular events of grade 3 or higher within 6 months prior to the first dose; c. New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) < 50%;
- Known severe pulmonary hypertension or uncontrolled systemic hypertension; uncontrolled hypertension (for individuals <60 years old, systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg; for individuals ≥ 60 years old, systolic blood pressure ≥ 150 mmHg and diastolic blood pressure ≥ 90 mmHg);
- Patients with symptomatic brain metastases requiring treatment;
- Individuals with severe or uncontrolled mental illness;
- Presence of active infections requiring systemic treatment or uncontrolled infections within 14 days prior to starting the investigational drug;
- Positive tests for antibodies to human immunodeficiency virus (HIV), hepatitis C virus (HCV), or Treponema pallidum; positive hepatitis B virus (HBV) surface antigen;
- History of right-to-left, bidirectional, or transient right-to-left cardiac shunts;
- History of alcohol or drug abuse/dependence;
- Participation in other clinical trials involving investigational drugs within 30 days prior to screening;
- Any medications or treatments deemed by the investigator to potentially interfere with trial data or cause severe side effects that have not been fully washed out prior to enrollment;
- Any other conditions deemed inappropriate for participation in this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qinglei Gao, PhD, MD, +86-13871127473, qingleigao@hotmail.com
Qinglei Gao, PhD, MD
About this study
Official title: Efficacy and Safety of FRD001 Injection in Ultrasound Contrast Imaging for the Differential Diagnosis of Benign and Malignant Ovarian Masses in Women
This is a Prospective, Self-Controlled, Open-Label, Multicenter Clinical Trial. The purpose of this study is to demonstrate the efficacy and safety of FRD001 injection in ultrasound contrast imaging for the differentiation between benign and malignant ovarian masses in women, using gray-scale and power Doppler ultrasound as controls. This trial will adopt a self-controlled design, where each participant will first undergo gray-scale/power Doppler ultrasound imaging, followed by FRD001 injection-enhanced ultrasound imaging. The target population is assumed to have a malignancy prevalence (P) of 40%, with an expected sensitivity of gray-scale/power Doppler ultrasound at 70%. It is hypothesized that the sensitivity of FRD001 injection-enhanced ultrasound will improve by 20%, reaching an anticipated sensitivity of 90%. The significance level (α) is set at 0.05, with a power (1-β) of 80%, and an inconsistency ratio (D) of 0.34. Based on these parameters, a total sample size (N) of 178 cases is required. Considering a 10% dropout rate, at least 198 subjects will be needed, which includes 79 participants with malignant tumors (N1) and 119 with benign conditions (N2). All screening assessments for each participant will be conducted within 7 days prior to the administration of the investigational medicinal product (IMP), including the day of administration. Safety observations will continue for 72 ± 24 hours post-IMP administration. Pathological results for the target lesions will be collected within 30 days following the IMP imaging examination. The efficacy of the IMP in differentiating between benign and malignant ovarian masses will be evaluated against pathological results, which will serve as the gold standard. This comprehensive approach will provide crucial insights into the diagnostic capabilities of FRD001 injection, potentially enhancing clinical decision-making in the management of ovarian masses.
- Conditions
- Ovary Cancer
- Being tested
- FRD001
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRD001Drug
FRD001 injection is a lipid-based second-generation ultrasound contrast agent. FRD001 injection in ultrasound contrast imaging could enhance the differentiation between benign and malignant ovarian masses in women, using gray-scale and power Doppler ultrasound as controls.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic cohort | Experimental | This trial will adopt a self-controlled design, where each participant will first undergo gray-scale/power Doppler ultrasound imaging, followed by FRD001 injection-enhanced ultrasound imaging. At least 198 subjects will be needed, which includes 79 participants with malignant tumors (N1) and 119 with benign conditions (N2). All screening assessments for each participant will be conducted within 7 days prior to the administration of the investigational medicinal product (IMP), including the day of administration. Safety observations will continue for 72 ± 24 hours post-IMP administration. Pathological results for the target lesions will be collected within 30 days following the IMP imaging examination. Receives: Drug: FRD001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The primary endpoint is sensitivity, calculated using pathological results as the gold standard, according to the previously established formulas.
Measured: 1 years
Secondary outcomes (2)
Specificity
The secondary endpoints include specificity, calculated using pathological results as the gold standard, according to the previously established formulas.
Measured: 1 years
Adverse events (AE) and serious adverse events (SAE)
Adverse events (AE) and serious adverse events (SAE) are assessed according to the common terminology criteria for adverse events (NCI-CTCAE) version 5.0. All adverse events occurring in subjects during the clinical trial are observed, and their clinical characteristics, severity, occurrence time, resolution time, management measures, and outcomes are recorded, along with an assessment of their correlation with the investigational drug.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CancerStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556342
- Sponsor's protocol ID
- 2024-TJ-FRDOC
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of FRD001 Injection in Ultrasound Contrast Imaging for the Differential Diagnosis of Benign and Malignant Ovarian Masses in Women
- ClinicalTrials.gov ID
- NCT06556342
- Acronym / sponsor ID
- 2024-TJ-FRDOC
- Conditions
- Ovary Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Prospective, Self-Controlled, Open-Label, Multicenter Clinical Trial. The purpose of this study is to demonstrate the efficacy and safety of FRD001 injection in ultrasound contrast imaging for the differentiation between benign and malignant ovarian masses in women, using gray-scale and power Doppler ultrasound as controls. This trial will adopt a self-controlled design, where each participant will first undergo gray-scale/power Doppler ultrasound imaging, followed by FRD001 injection-enhanced ultrasound imaging. The target population is assumed to have a malignancy prevalence (P) of 40%, with an expected sensitivity of gray-scale/power Doppler ultrasound at 70%. It is hypothesized that the sensitivity of FRD001 injection-enhanced ultrasound will improve by 20%, reaching an anticipated sensitivity of 90%. The significance level (α) is set at 0.05, with a power (1-β) of 80%, and an inconsistency ratio (D) of 0.34. Based on these parameters, a total sample size (N) of 178 cases is required. Considering a 10% dropout rate, at least 198 subjects will be needed, which includes 79 participants with malignant tumors (N1) and 119 with benign conditions (N2). All screening assessments for each participant will be conducted within 7 days prior to the administration of the investigational medicinal product (IMP), including the day of administration. Safety observations will continue for 72 ± 24 hours post-IMP administration. Pathological results for the target lesions will be collected within 30 days following the IMP imaging examination. The efficacy of the IMP in differentiating between benign and malignant ovarian masses will be evaluated against pathological results, which will serve as the gold standard. This comprehensive approach will provide crucial insights into the diagnostic capabilities of FRD001 injection, potentially enhancing clinical decision-making in the management of ovarian masses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic cohort | Experimental | Drug: FRD001This trial will adopt a self-controlled design, where each participant will first undergo gray-scale/power Doppler ultrasound imaging, followed by FRD001 injection-enhanced ultrasound imaging. At least 198 subjects will be needed, which includes 79 participants with malignant tumors (N1) and 119 with benign conditions (N2). All screening assessments for each participant will be conducted within 7 days prior to the administration of the investigational medicinal product (IMP), including the day of administration. Safety observations will continue for 72 ± 24 hours post-IMP administration. Pathological results for the target lesions will be collected within 30 days following the IMP imaging examination. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All participants must meet the following inclusion criteria to be eligible for enrollment in this study:
- Female participants aged 18 to 75 years (inclusive of the age limits);
- Patients with untreated unilateral or bilateral, unilocular or multilocular cystic/solid masses;
- Expected survival of at least 3 months;
- ECOG performance status of 0 to 2 for participants with malignant tumors;
Key exclusion criteria (21 listed)
- Patients with benign teratomas;
- Patients who have undergone total removal of the uterine appendages;
- Patients with congenital malformations of the reproductive system;
- Patients who have received radiotherapy, chemotherapy, or invasive procedures (including but not limited to radiofrequency ablation) during the administration of the investigational medicinal product (IMP) and the confirmatory diagnostic examination;
- Women planning to become pregnant within 6 months, currently pregnant, or breastfeeding, or women of childbearing potential with a positive pregnancy test during the screening period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRD001FRD001 injection is a lipid-based second-generation ultrasound contrast agent. FRD001 injection in ultrasound contrast imaging could enhance the differentiation between benign and malignant ovarian masses in women, using gray-scale and power Doppler ultrasound as controls. | Drug | Diagnostic cohort |
Primary outcome
Sensitivity
Time frame: 1 years
The primary endpoint is sensitivity, calculated using pathological results as the gold standard, according to the previously established formulas.
2 secondary outcomes
Specificity
Time frame: 1 years
Adverse events (AE) and serious adverse events (SAE)
Time frame: 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Ovary Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRD001 in people with Ovary Cancer, run by Tongji 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 8 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 16 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qinglei Gao, PhD (15391566981, qingleigao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2024.