Validity of Blood Pool SUV Ratio in Identification of Malignancy in Case of Diseased LiverNCT05258045
Validity of Mediastinal Blood Pool SUV Ratio
An observational study of Validity of Blood Pool SUV Ratio in Identification of Malignancy in Case of Diseased Liver, run by Assiut University.
Trial summary
-Validity of blood pool SUV ratio in identification of malignancy in case of diseased liver. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Validity of Blood Pool SUV Ratio in Identification of Malignancy in Case of Diseased Liver
- What is being tested?
- F18 FDG
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 30 Dec 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Cross sectional study prospective and retrospective
Who may be able to join
- This study will include cancer pt who did PET/CT scan who presented to nuclear medicine unit during the period from 2021 until the end of the study.
Who cannot join
- Severely ill patient
- Pt with glucose level above 200
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Is Mediastinal Blood Pool SUV Ratio Valid in Identification of Malignancy in Comparison to Liver SUV Ratio?
-Validity of blood pool SUV ratio in identification of malignancy in case of diseased liver.
Read the detailed description
PET/CT is the functional imaging tool that can measure increased glucose metabolism in cancer tissues by using flourine 18 FDG which is FDA approved and used routinely in identification of malignant lesions , staging and restaging of many malignancy like lymphoma, breast cancer, lung cancer and cancer colon.
In clinical routine, SUV is often used to determine the glucose metabolism in tumours by 18F-FDG PET/CT. And can be further normalised to SUVs in reference regions resulting in a SUV ratio (SUV ratio).in routine work SUV of the lesion is normalised to SUV of the liver , but this not used if the liver is diseased like as liver cirrhosis or liver metastases , so SUV ratio of lesion to mediastinal blood pool and SUV ratio of the lesion to liver will be measured in correlation to pathology to assess validity of SUV of mediastinal blood pool.
- Conditions
- Validity of Blood Pool SUV Ratio in Identification of Malignancy in Case of Diseased Liver
- Being tested
- F18 FDG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F18 FDGRadiation
Radioactive material
| Study group | Role | What they receive |
|---|---|---|
| SUV ratio of mediastinal blood pool to the lesion and SUV ratio of liver to lesion | Avidity of SUV of blood pool Receives: Radiation: F18 FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Validity of blood pool suv ratio in identification of malignancy in case of diseased liver.
PET/CT is the functional imaging tool that can measure increased glucose metabolism in cancer tissues by using flourine 18 FDG which is FDA approved and used routinely in identification of malignant lesions , staging and restaging of many maligancy like lymphoma, breast cancer, lung cancer and cancer colon.
In clinical routine, SUV is often used to determine the glucose metabolism in tumours by 18F-FDG PET/CT. And can be further normalised to SUVs in reference regions resulting in a SUV ratio (SUV ratio).in routine work SUV of the lesion is normalised to SUV of the liver , but this not used if the liver is diseased like as liver cirrhosis or liver metastases , so SUV ratio of lesion to mediastinal blood pool and SUV ratio of the lesion to liver will be measured in correlation to pathology to assess validity of SUV of mediastinal blood pool.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validity of Blood Pool SUV Ratio in Identification of Malignancy in Case of Diseased LiverStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Fathy Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258045
- Sponsor's protocol ID
- PET/CT in malignancy
- Status last verified
- Feb 2022
- First submitted
- 22 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Mediastinal Blood Pool SUV Ratio Valid in Identification of Malignancy in Comparison to Liver SUV Ratio?
- ClinicalTrials.gov ID
- NCT05258045
- Acronym / sponsor ID
- PET/CT in malignancy
- Conditions
- Validity of Blood Pool SUV Ratio in Identification of Malignancy in Case of Diseased Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 28 Feb 2022 (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.
-Validity of blood pool SUV ratio in identification of malignancy in case of diseased liver.
Detailed description
PET/CT is the functional imaging tool that can measure increased glucose metabolism in cancer tissues by using flourine 18 FDG which is FDA approved and used routinely in identification of malignant lesions , staging and restaging of many malignancy like lymphoma, breast cancer, lung cancer and cancer colon.
In clinical routine, SUV is often used to determine the glucose metabolism in tumours by 18F-FDG PET/CT. And can be further normalised to SUVs in reference regions resulting in a SUV ratio (SUV ratio).in routine work SUV of the lesion is normalised to SUV of the liver , but this not used if the liver is diseased like as liver cirrhosis or liver metastases , so SUV ratio of lesion to mediastinal blood pool and SUV ratio of the lesion to liver will be measured in correlation to pathology to assess validity of SUV of mediastinal blood pool.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUV ratio of mediastinal blood pool to the lesion and SUV ratio of liver to lesion | – | Radiation: F18 FDGAvidity of SUV of blood pool |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Cross sectional study prospective and retrospective
Key inclusion criteria (1 listed)
- This study will include cancer pt who did PET/CT scan who presented to nuclear medicine unit during the period from 2021 until the end of the study.
Key exclusion criteria (2 listed)
- Severely ill patient
- Pt with glucose level above 200
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 |
|---|---|---|
| F18 FDGRadioactive material | Radiation | SUV ratio of mediastinal blood pool to the lesion and SUV ratio of liver to lesion |
Primary outcome
-Validity of blood pool suv ratio in identification of malignancy in case of diseased liver.
Time frame: One year
PET/CT is the functional imaging tool that can measure increased glucose metabolism in cancer tissues by using flourine 18 FDG which is FDA approved and used routinely in identification of malignant lesions , staging and restaging of many maligancy like lymphoma, breast cancer, lung cancer and cancer colon. In clinical routine, SUV is often used to determine the glucose metabolism in tumours by 18F-FDG PET/CT. And can be further normalised to SUVs in reference regions resulting in a SUV ratio (SUV ratio).in routine work SUV of the lesion is normalised to SUV of the liver , but this not used if the liver is diseased like as liver cirrhosis or liver metastases , so SUV ratio of lesion to mediastinal blood pool and SUV ratio of the lesion to liver will be measured in correlation to pathology to assess validity of SUV of mediastinal blood pool.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Validity of Blood Pool SUV Ratio in Identification of Malignancy in Case of Diseased Liver, run by Assiut University.
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 1 inclusion and 2 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 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Zainab Fathy Mohammed, Resident doctor (01099024404, zainab.fathy.95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-Validity of blood pool suv ratio in identification of malignancy in case of diseased liver. (time frame: One year). 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 28 Feb 2022.