Metastatic DiseaseNCT04492735
The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid Malignancies
An observational study of Metastatic Disease and Primary Tumor, run by Roshni Dasgupta at 1 site in United States.
Trial summary
Use of indocyanine green will augment the accuracy of identification and resection of both primary solid malignancies as well as their pulmonary metastases, where applicable We will conduct a prospective feasibility study of pediatric patients with solid malignancies with or without lung metastatases who present at… Read more about this study
- Who is it for?
- Ages 1 day to 45 years
- Conditions the study is for
- Metastatic Disease, Primary Tumor, Solid Malignancies
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2020to Jun 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 1 day to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Oncology solid, primary malignancies or their related metastatic lesion
Who may be able to join
- All patients with newly diagnosed solid, primary malignancies or their related metastatic lesions.
- Diagnosis of primary or metastatic malignancy will be made by combination of:
- Clinical evaluation and physical exam
- Radiologic study including ultrasound, CT scan, and/or MRI
- Pathologic diagnosis after biopsy
Who cannot join
- Those patients and parents/guardians unwilling to provide consent/assent.
- Pregnant and/or women who are breast feeding.
- Patients with Iodine allergies
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Erin Watters, 513-803-7024, erin.watters@cchmc.org
About this study
Official title: The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid
Use of indocyanine green will augment the accuracy of identification and resection of both primary solid malignancies as well as their pulmonary metastases, where applicable We will conduct a prospective feasibility study of pediatric patients with solid malignancies with or without lung metastatases who present at the time of initial diagnosis or relapse. These patients will receive a targeted dye to aid in the resection of these metastases. We plan to assess ICG as it relates to:
- Diagnostic accuracy using pathologic correlation as gold standard measure
- Short and long term event free and overall survival
Read the detailed description
Patients diagnosed with solid malignancies or metastatic lesions who require clinically indicated resection will be identified by their Oncologist. The oncologist will inform the subject/family about the study and ask if they may be interested in participating. If the subject/family demonstrates potential interest in the study, the Pediatric Surgery Research team will discuss the risks and benefits of pre-operative ICG administration with the patients and enrollment.
Study subjects: All patients diagnosed with solid malignancies as well as those with metastatic disease distant from the primary tumor will be potentially eligible for the study. Diagnosis will be made:
- In a multimodal fashion including physical exam, radiologic evaluation (ultrasound, MRI, CT scan, etc), and sometimes biopsy.
- Prior to definitive surgical resection of the newly diagnosed malignancy
- Conditions
- Metastatic Disease, Primary Tumor, Solid Malignancies
- Medical subject headings
- Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy using pathologic correlation as gold standard measure
Measured: 2 years
Short and long term event free and overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start5 Jun 2020
- Primary completionDec 2023 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roshni Dasgupta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roshni Dasgupta, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492735
- Sponsor's protocol ID
- PSORC ICG
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid
- ClinicalTrials.gov ID
- NCT04492735
- Acronym / sponsor ID
- PSORC ICG
- Conditions
- Metastatic Disease, Primary Tumor, Solid Malignancies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Roshni DasguptaUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 Jul 2020 (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.
Use of indocyanine green will augment the accuracy of identification and resection of both primary solid malignancies as well as their pulmonary metastases, where applicable We will conduct a prospective feasibility study of pediatric patients with solid malignancies with or without lung metastatases who present at the time of initial diagnosis or relapse. These patients will receive a targeted dye to aid in the resection of these metastases. We plan to assess ICG as it relates to:
- Diagnostic accuracy using pathologic correlation as gold standard measure
- Short and long term event free and overall survival
Detailed description
Patients diagnosed with solid malignancies or metastatic lesions who require clinically indicated resection will be identified by their Oncologist. The oncologist will inform the subject/family about the study and ask if they may be interested in participating. If the subject/family demonstrates potential interest in the study, the Pediatric Surgery Research team will discuss the risks and benefits of pre-operative ICG administration with the patients and enrollment.
Study subjects: All patients diagnosed with solid malignancies as well as those with metastatic disease distant from the primary tumor will be potentially eligible for the study. Diagnosis will be made:
- In a multimodal fashion including physical exam, radiologic evaluation (ultrasound, MRI, CT scan, etc), and sometimes biopsy.
- Prior to definitive surgical resection of the newly diagnosed malignancy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Oncology solid, primary malignancies or their related metastatic lesion
Key inclusion criteria (5 listed)
- All patients with newly diagnosed solid, primary malignancies or their related metastatic lesions.
- Clinical evaluation and physical exam
- Radiologic study including ultrasound, CT scan, and/or MRI
- Pathologic diagnosis after biopsy
Key exclusion criteria (3 listed)
- Those patients and parents/guardians unwilling to provide consent/assent.
- Pregnant and/or women who are breast feeding.
- Patients with Iodine allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy using pathologic correlation as gold standard measure
Time frame: 2 years
Short and long term event free and overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Disease and Primary Tumor, run by Roshni Dasgupta at 1 site in United States.
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 5 inclusion and 3 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 30 Jul 2020. 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 United States. 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 Erin Watters (513-803-7024, erin.watters@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy using pathologic correlation as gold standard measure (time frame: 2 years). 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?
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 30 Jul 2020.