LymphomaNCT04158414
Applying PET/MR in Oncology - a Prospective Project
A study testing PET/MR scan in people with Lymphoma and Nasopharyngeal Cancer, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Cancer is a global health issue. According to the World Health Organization, Cancer is the second leading cause of death globally, and is responsible for an estimated 9.6 million deaths in 2018. In Israel, more than 30,000 new cases of cancer were diagnosed, and more than 11,000 deaths were cancer-related during 2016. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma, Nasopharyngeal Cancer, Esophageal Cancer
- What is being tested?
- PET/MR scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2019to 28 Nov 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
- patients diagnosed in One of the cancers being investigated.
- Only in Sarcoma:20 children and adults with newly diagnosed sarcomas. Children will be included if can perform the study without sedation, and with written parental approval.
Who cannot join
- Patients younger than 18 years.
- Pregnancy/
- Patients contraindication to MRI or to intravenous gadolinium injection.
About this study
Cancer is a global health issue. According to the World Health Organization, Cancer is the second leading cause of death globally, and is responsible for an estimated 9.6 million deaths in 2018. In Israel, more than 30,000 new cases of cancer were diagnosed, and more than 11,000 deaths were cancer-related during 2016.
Imaging plays a pivotal role in cancer management, and multiple techniques are used in all phases of cancer management. The overall morphological, structural, metabolic and functional information obtained in imaging is used for improved individualized therapy planning. Different imaging modalities are available during different time points in the natural history of different malignancies:
Read more
Early detection of cancer through screening based on imaging is probably a major contributor to a reduction in mortality for certain cancers .
Once a diagnosis is made, determining the clinical stage of cancer, meaning the extent of the disease before any treatment is given, is a critical element in determining appropriate treatment based on the experience and outcomes of groups of previous patients with similar stage . Precise clinical staging of cancer is crucial. Not only that this clear non-ambiguous description is a key factor that defines prognosis, it is also a chief component of inclusion, exclusion, and stratification criteria for clinical trials. Several cancer staging systems are used worldwide. The most clinically useful staging system is the tumor, node, and metastasis (TNM) staging system developed by the American Joint Committee on Cancer (AJCC) in collaboration with the Union for International Cancer Control (UICC). The AJCC TNM system classifies cancers by the size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M). There is a TNM staging algorithm for cancers of virtually every anatomic site and histology, with the primary exception of pediatric cancers. The clinical TNM (cTNM) classification should be used to determine correctly the clinical stage of cancer and to help guide primary therapy planning.
Read the detailed description
Stage may be defined at several time points during the monitoring period of cancer patients. When using imaging obtained during the relevant time frame, one may use one of the other TNM categories to stage correctly the cancer:
For example, imaging is of high value in assessing therapy response during and after systemic and/or radiation therapy is given . Using imaging data and the clinical posttherapy TNM classification (ycTNM) is helpful in determining the patient's response to treatment.
In case a patient is given the systemic therapy as a neoadjuvant therapy before a planned curative surgery, imaging may categorize the patient as a responder vs non-responder. If categorized as an early non-responder, another therapy or an upfront surgery may be advised, while eliminating therapy toxicity. If imaging, however, supports major response to treatment, more conservative treatment and avoidance of surgical intervention may be considered and change patients quality of life dramatically.
In patients given a systemic therapy as a curative or a palliative therapy, assessing the response via imaging is crucial as well - if imaging studies support a progressive disease, changing therapy protocol is advised. In a disease controlled by the therapy, imaging may aid in guiding follow-up schedule, lifestyle and medical management.
In the context of therapy response assessment, imaging is also important in assessing side effects of the therapy. Imaging may identify radiation-induced injuries, and may recognize pathologies associated with chemotherapy, biologic and immunotherapy.
Imaging is also critical when recurrence of malignant disease is suspected. In such cases, when signs or symptoms suggest local recurrence, or when raised level of a tumor marker is documented, different imaging techniques can dramatically guide restaging of the disease using the recurrence-TNM classification (rTNM). In such cases imaging may localize the recurrent disease and may guide surgical/radiation/systemic therapy .
Different imaging modalities allow assessment of virtually every cancer site and in every time frame during the continuum of the disease. Imaging aids in assessing tumor's size, location, and relationship to normal anatomic structures, as well as the existence of nodal and/or distant metastatic disease. Among the most commonly used imaging modalities are computed tomography (CT), magnetic resonance (MR) imaging, positron emission tomography (PET) and ultrasound. In addition to providing key information for assigning the T, N, and M categories, imaging is invaluable for guiding biopsies and surgical resections.
PET imaging has revolutionized the imaging evaluation of cancer . By exploiting biochemical and physiologic differences between tumor cells and normal tissues , PET imaging has become
- Conditions
- Lymphoma, Nasopharyngeal Cancer, Esophageal Cancer, Cervical Cancer, Hepatobiliary Cancer, Pancreatic Cancer
- Being tested
- PET/MR scan
- Medical subject headings
- Lymphoma, Nasopharyngeal Neoplasms, Esophageal Neoplasms, Uterine Cervical Neoplasms, Pancreatic Neoplasms, Sarcoma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR scanDiagnostic test
500 cancer patients referred to PET-CT assessment will undergo PET/MR scan as well, and the net data will be compared. The overall data will be investigated in groups and subgroups of patients that share similar clinical characteristics and represent cancer patients in different time points during the natural history of their disease. Data analysis will be performed both visually and quantitatively using different MR and PET parameters according to the patient group. Specific populations will be detailed in the next sections per malignancy.
| Study group | Role | What they receive |
|---|---|---|
| Different types of cancer Patients | Experimental | Lymphoma,Nasopharyngeal Cancer; Esophageal Cancer, Cervical cancer; Hepatobiliary and pancreatic cancer; Sarcoma; Prostate Cancer Receives: Diagnostic Test: PET/MR scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who preformed PET/MR and PET/CT in clinical staging and monitoring of different cancer types will be measured and reported number of Participants in staging and different between their scans/
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 posted8 Nov 2019
- Study start28 Nov 2019 (estimated)
- Primary completion28 Jan 2020 (estimated)
- Study completion28 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT04158414
- Sponsor's protocol ID
- TASMC-19-ES-0568-CTIL
- Status last verified
- Nov 2019
- First submitted
- 29 Oct 2019
- Last updated
- 8 Nov 2019
- 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 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying PET/MR in Oncology - a Prospective Project
- ClinicalTrials.gov ID
- NCT04158414
- Acronym / sponsor ID
- TASMC-19-ES-0568-CTIL
- Conditions
- Lymphoma, Nasopharyngeal Cancer, Esophageal Cancer, Cervical Cancer, Hepatobiliary Cancer, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 28 Nov 2019 (estimated)
- Primary completion
- 28 Jan 2020 (estimated)
- Study completion
- 28 Nov 2021 (estimated)
- First posted
- 8 Nov 2019 (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.
Cancer is a global health issue. According to the World Health Organization, Cancer is the second leading cause of death globally, and is responsible for an estimated 9.6 million deaths in 2018. In Israel, more than 30,000 new cases of cancer were diagnosed, and more than 11,000 deaths were cancer-related during 2016.
Imaging plays a pivotal role in cancer management, and multiple techniques are used in all phases of cancer management. The overall morphological, structural, metabolic and functional information obtained in imaging is used for improved individualized therapy planning. Different imaging modalities are available during different time points in the natural history of different malignancies:
Early detection of cancer through screening based on imaging is probably a major contributor to a reduction in mortality for certain cancers .
Once a diagnosis is made, determining the clinical stage of cancer, meaning the extent of the disease before any treatment is given, is a critical element in determining appropriate treatment based on the experience and outcomes of groups of previous patients with similar stage . Precise clinical staging of cancer is crucial. Not only that this clear non-ambiguous description is a key factor that defines prognosis, it is also a chief component of inclusion, exclusion, and stratification criteria for clinical trials. Several cancer staging systems are used worldwide. The most clinically useful staging system is the tumor, node, and metastasis (TNM) staging system developed by the American Joint Committee on Cancer (AJCC) in collaboration with the Union for International Cancer Control (UICC). The AJCC TNM system classifies cancers by the size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M). There is a TNM staging algorithm for cancers of virtually every anatomic site and histology, with the primary exception of pediatric cancers. The clinical TNM (cTNM) classification should be used to determine correctly the clinical stage of cancer and to help guide primary therapy planning.
Detailed description
Stage may be defined at several time points during the monitoring period of cancer patients. When using imaging obtained during the relevant time frame, one may use one of the other TNM categories to stage correctly the cancer:
For example, imaging is of high value in assessing therapy response during and after systemic and/or radiation therapy is given . Using imaging data and the clinical posttherapy TNM classification (ycTNM) is helpful in determining the patient's response to treatment.
In case a patient is given the systemic therapy as a neoadjuvant therapy before a planned curative surgery, imaging may categorize the patient as a responder vs non-responder. If categorized as an early non-responder, another therapy or an upfront surgery may be advised, while eliminating therapy toxicity. If imaging, however, supports major response to treatment, more conservative treatment and avoidance of surgical intervention may be considered and change patients quality of life dramatically.
In patients given a systemic therapy as a curative or a palliative therapy, assessing the response via imaging is crucial as well - if imaging studies support a progressive disease, changing therapy protocol is advised. In a disease controlled by the therapy, imaging may aid in guiding follow-up schedule, lifestyle and medical management.
In the context of therapy response assessment, imaging is also important in assessing side effects of the therapy. Imaging may identify radiation-induced injuries, and may recognize pathologies associated with chemotherapy, biologic and immunotherapy.
Imaging is also critical when recurrence of malignant disease is suspected. In such cases, when signs or symptoms suggest local recurrence, or when raised level of a tumor marker is documented, different imaging techniques can dramatically guide restaging of the disease using the recurrence-TNM classification (rTNM). In such cases imaging may localize the recurrent disease and may guide surgical/radiation/systemic therapy .
Different imaging modalities allow assessment of virtually every cancer site and in every time frame during the continuum of the disease. Imaging aids in assessing tumor's size, location, and relationship to normal anatomic structures, as well as the existence of nodal and/or distant metastatic disease. Among the most commonly used imaging modalities are computed tomography (CT), magnetic resonance (MR) imaging, positron emission tomography (PET) and ultrasound. In addition to providing key information for assigning the T, N, and M categories, imaging is invaluable for guiding biopsies and surgical resections.
PET imaging has revolutionized the imaging evaluation of cancer . By exploiting biochemical and physiologic differences between tumor cells and normal tissues , PET imaging has become
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 Patients | Experimental | Diagnostic Test: PET/MR scanLymphoma,Nasopharyngeal Cancer; Esophageal Cancer, Cervical cancer; Hepatobiliary and pancreatic cancer; Sarcoma; Prostate Cancer |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients diagnosed in One of the cancers being investigated.
- Only in Sarcoma:20 children and adults with newly diagnosed sarcomas. Children will be included if can perform the study without sedation, and with written parental approval.
Key exclusion criteria (3 listed)
- Patients younger than 18 years.
- Pregnancy/
- Patients contraindication to MRI or to intravenous gadolinium injection.
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 |
|---|---|---|
| PET/MR scan500 cancer patients referred to PET-CT assessment will undergo PET/MR scan as well, and the net data will be compared. The overall data will be investigated in groups and subgroups of patients that share similar clinical characteristics and represent cancer patients in different time points during the natural history of their disease. Data analysis will be performed both visually and quantitatively using different MR and PET parameters according to the patient group. Specific populations will be detailed in the next sections per malignancy. | Diagnostic test | Different types of cancer Patients |
Primary outcome
Patients who preformed PET/MR and PET/CT in clinical staging and monitoring of different cancer types will be measured and reported number of Participants in staging and different between their scans/
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MR scan in people with Lymphoma and Nasopharyngeal Cancer, run by Tel-Aviv Sourasky Medical Center.
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 2 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 8 Nov 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients who preformed PET/MR and PET/CT in clinical staging and monitoring of different cancer types will be measured and reported number of Participants in staging and different between their scans/ (time frame: 1 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 8 Nov 2019.