Different Types of CancerNCT04441606
The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies
A study testing 68Ga-FAPI-04 PET/CT in people with Different Types of Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over 18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other imaging studies, better delineation of tumor… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Different Types of Cancer
- What is being tested?
- 68Ga-FAPI-04 PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Jun 2020to Jul 2021
- Phase
- Interventional
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to:
- Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.
- Better delineation of tumor extent prior to therapy
- Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma).
- Patients unable to optimally comply with the required preparation for FDG imaging.
- The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff.
Who cannot join
- Age < 18 years.
- Pregnant females.
- Patients who are reluctant to undergo both FDG and FAPI PET scans.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky medial center
Tel Aviv
IRA DANA, +97236974373, irako@tlvmc.gov.il
YANA ABRAMOV, +97236974373, irako@tlvmc.gov.il
About this study
The aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over 18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other imaging studies, better delineation of tumor extent prior to therapy, and with emphasis on malignancies known to show variable avidity to FDG and at times, no uptake at all. Also patients unable to optimally comply with the required preparation for FDG imaging, such as diabetic patients who struggle in achieving glycemic control.
- Conditions
- Different Types of Cancer
- Being tested
- 68Ga-FAPI-04 PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-04 PET/CTRadiation
- Patients will undergo two scans: first a routine FDG PET scan and a FAPI PET scan, within 10 days.
- Scans will be interpreted by board certified Nuclear medicine physicians and board certified radiologists.
- Immunohistochemical analysis with specific staining for FAP will be performed in removed malignant tissues, either at surgery or from biopsy, to assess a possible correlation between the intensity of uptake and the level of FAP expression.
| Study group | Role | What they receive |
|---|---|---|
| Different types of cancer | Experimental | The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to:
1. Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.
2. Better delineation of tumor extent prior to therapy
3. Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma).
4. Patients unable to optimally comply with the required preparation for FDG imaging.
* The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff. Receives: Radiation: 68Ga-FAPI-04 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who preformed 68Ga-FAPI-04 PSMA.
To evaluate the avidity of various cancers to 68Ga-FAPI-04.
Measured: 1 year
Patients who preformed 68Ga-FAPI-04 PSMA and PET/CT FDG.
To compare the detectability of FAPI-04 and FDG for malignant lesions.
Measured: 1 year
Patients who preformed 68Ga-FAPI-04 PSMA and PET/MRI.
To evaluate the potential impact of 68Ga-FAPI-04 PET/CT and/or PET/MRI on patient management.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start11 Jun 2020
- Primary completion17 Jun 2020
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Different Types of CancerStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441606
- Sponsor's protocol ID
- TASMC-20-ES-0308-CTIL
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2020
- Last updated
- 11 Feb 2021
- 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 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies
- ClinicalTrials.gov ID
- NCT04441606
- Acronym / sponsor ID
- TASMC-20-ES-0308-CTIL
- Conditions
- Different Types of Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 22 Jun 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.
The aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over 18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other imaging studies, better delineation of tumor extent prior to therapy, and with emphasis on malignancies known to show variable avidity to FDG and at times, no uptake at all. Also patients unable to optimally comply with the required preparation for FDG imaging, such as diabetic patients who struggle in achieving glycemic control.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Different types of cancer | Experimental | Radiation: 68Ga-FAPI-04 PET/CTThe study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to: 1. Inconclusive findings on 18F-FDG PET/CT or other imaging modalities. 2. Better delineation of tumor extent prior to therapy 3. Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma). 4. Patients unable to optimally comply with the required preparation for FDG imaging. * The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to:
- Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.
- Better delineation of tumor extent prior to therapy
- Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma).
- Patients unable to optimally comply with the required preparation for FDG imaging.
Key exclusion criteria (3 listed)
- Age < 18 years.
- Pregnant females.
- Patients who are reluctant to undergo both FDG and FAPI PET scans.
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 |
|---|---|---|
| 68Ga-FAPI-04 PET/CT* Patients will undergo two scans: first a routine FDG PET scan and a FAPI PET scan, within 10 days. * Scans will be interpreted by board certified Nuclear medicine physicians and board certified radiologists. * Immunohistochemical analysis with specific staining for FAP will be performed in removed malignant tissues, either at surgery or from biopsy, to assess a possible correlation between the intensity of uptake and the level of FAP expression. | Radiation | Different types of cancer |
Primary outcome
Patients who preformed 68Ga-FAPI-04 PSMA.
Time frame: 1 year
To evaluate the avidity of various cancers to 68Ga-FAPI-04.
Patients who preformed 68Ga-FAPI-04 PSMA and PET/CT FDG.
Time frame: 1 year
To compare the detectability of FAPI-04 and FDG for malignant lesions.
Patients who preformed 68Ga-FAPI-04 PSMA and PET/MRI.
Time frame: 1 year
To evaluate the potential impact of 68Ga-FAPI-04 PET/CT and/or PET/MRI on patient management.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Different Types of Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 2
Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
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?
A study testing 68Ga-FAPI-04 PET/CT in people with Different Types of Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 6 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 11 Feb 2021. 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 Israel. 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 IRA DANA (+97236974373, irako@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients who preformed 68Ga-FAPI-04 PSMA. (time frame: 1 year). The study lists 3 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 11 Feb 2021.