Soft Tissue SarcomasNCT00687778
11C-Acetate PET/CT Non-FDG-Avid Tumors
An observational study of Soft Tissue Sarcomas and Thyroid Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
F18-FDG is the widely used PET tracer in the routine practice of oncologic disease imaging using the technology of PET-CT. However, FDG-avidity is a characteristic of the individual tumor. There are various types of human malignancies, which are not taking FDG in access. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Soft Tissue Sarcomas, Thyroid Cancer, Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Jun 2010
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients with newly diagnosed tumors, which are often non-FDG avid or show only low intensity uptake: Soft tissue sarcomas, well-differentiated thyroid cancer, well-differentiated and bronchoalveolar lung cancer, indolent lymphomas, neuroendocrine tumors, GIST, uterine malignancies, mucin-producing cancer, teratoma, hepatoma, HCC and lobular breast carcinoma.
Who may be able to join
- patients with newly diagnosed tumors, which are often non-FDG avid or show only low intensity uptake:
- Soft tissue sarcomas
- well-differentiated thyroid cancer
- well-differentiated and bronchoalveolar lung cancer
- indolent lymphomas
- neuroendocrine tumors
Show all 14Show fewer
- GIST
- uterine malignancies
- mucin-producing cancer
- teratoma
- hepatoma
- HCC
- lobular breast carcinoma
- Patients over the age of 18
Who cannot join
- patients under the age of 18 years
- pregnant and lactating women
- claustrophobic patients
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Einat Even-Sapir, MD, PhD, 972-3-697-3536, evensap@tasmc.health.gov.il
Limor Zuriel, MSc, 972-3-697-3536, limorz@tasmc.health.gov.il
About this study
F18-FDG is the widely used PET tracer in the routine practice of oncologic disease imaging using the technology of PET-CT. However, FDG-avidity is a characteristic of the individual tumor. There are various types of human malignancies, which are not taking FDG in access. In these cases FDG is not a sensitive tracer of imaging. In search for other tumor PET tracers, C11-Acetate has been shown recently in a few early studies to have a potential value in imaging of non-FDG-avid tumors.
The purpose of the current study is to assess the role of 11C-acetate PET in various tumors, which often are not detected by 18F-FDG and were not widely assessed until now.
Read the detailed description
Recent publications have suggested the use of 11C-acetate as another PET tracer for tumor imaging. The accumulation of 11C-acetate in tumor cells is related to the highly active lipid metabolism in the cell membrane associated with tumor growth. 11C-acetate is channeled into the tricarboxylic acid cycle via acetyl coenzyme A and then incorporated via phosphatidylcholine into the cell membrane's phopholipids. Possible biochemical paths of acetate incorporation or accumulation include (a) entering the Krebs cycle from acetyl coenzyme A (acetyl CoA) or as an intermediate metabolite, (b) esterification to form acetyl CoA as a major precursor in ß-oxidation for fatty acid synthesis, (c) combining with glycine in heme synthesis, and (d) through citrate for cholesterol synthesis. Of all of these possible metabolic pathways, participation in free fatty acid (lipid) synthesis is believed to be the dominant method of incorporation in tumors.
The clinical data on the role of 11C-acetate PET in human tumors is being accumulated. Most clinical studies have investigated the role of 11C-acetate PET in detection of prostate cancer. 11C-acetate PET was found valuable in the detection of recurrent prostate cancer, both in the prostate bed, lymph nodes and distant metastases. The main advantage of 11C-acetate is that it does not show physiological accumulation in the urinary bladder as is the case with 18F -FDG and therefore may be appropriate for the detection of active pelvic disease.
Comparing the uptake of 18F-FDG and of 11C-acetate in patients with lung carcinoma, the latter was found superior in the identification of a bronchiolo-alveolar carcinoma which often show no intense FDG uptake.
In the case of hepatic masses, well-differentiated HCC tumors were detect by 11C-acetate while poorly differentiated types were detected by 18F-FDG.
These data suggest that 11C-acetate PET may be valuable in the detection of well-differentiation slow growing tumors and may have a complementary role to the routinely used 18F-FDG.
- Conditions
- Soft Tissue Sarcomas, Thyroid Cancer, Lung Cancer, Indolent Lymphoma, Neuroendocrine Tumors, GIST
- Keywords
- C11-Acetate, FDG, sarcoma, Measurement of C11-Acetate uptake in tumors which are often non-FDG avid., Soft tissue sarcomas, well-differentiated thyroid cancer, well-differentiated and bronchoalveolar lung cancer, indolent lymphomas, neuroendocrine tumors, GIST, uterine malignancies, mucin-producing cancer, teratoma, hepatoma, HCC, lobular breast carcinoma
- Medical subject headings
- Sarcoma, Thyroid Neoplasms, Lung Neoplasms, Neuroendocrine Tumors, Carcinoma, Hepatocellular, Carcinoma, Lobular, Teratoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 100 patients with newly diagnosed tumors, which are often non-FDG avid or show only low intensity uptake: Soft tissue sarcomas, well-differentiated thyroid cancer, well-differentiated and bronchoalveolar lung cancer, indolent lymphomas, neuroendocrine tumors, GIST, uterine malignancies, mucin-producing cancer, teratoma, hepatoma, HCC and lobular breast carcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of C11-Acetate and F18-FDG in tumor will be measured in SUV PET units
Measured: At completion of acuisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomasStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Einat Even-Sapir, MD, PhD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687778
- Sponsor's protocol ID
- TASMC-08-EE-109-CTIL
- Status last verified
- May 2008
- First submitted
- 28 May 2008
- Last updated
- 2 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 11C-Acetate PET/CT Non-FDG-Avid Tumors
- ClinicalTrials.gov ID
- NCT00687778
- Acronym / sponsor ID
- TASMC-08-EE-109-CTIL
- Conditions
- Soft Tissue Sarcomas, Thyroid Cancer, Lung Cancer, Indolent Lymphoma, Neuroendocrine Tumors, GIST
- Keywords
- C11-Acetate, FDG, sarcoma, Measurement of C11-Acetate uptake in tumors which are often non-FDG avid., Soft tissue sarcomas, well-differentiated thyroid cancer, well-differentiated and bronchoalveolar lung cancer, indolent lymphomas, neuroendocrine tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 2 Jun 2008 (estimated)
- 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.
F18-FDG is the widely used PET tracer in the routine practice of oncologic disease imaging using the technology of PET-CT. However, FDG-avidity is a characteristic of the individual tumor. There are various types of human malignancies, which are not taking FDG in access. In these cases FDG is not a sensitive tracer of imaging. In search for other tumor PET tracers, C11-Acetate has been shown recently in a few early studies to have a potential value in imaging of non-FDG-avid tumors.
The purpose of the current study is to assess the role of 11C-acetate PET in various tumors, which often are not detected by 18F-FDG and were not widely assessed until now.
Detailed description
Recent publications have suggested the use of 11C-acetate as another PET tracer for tumor imaging. The accumulation of 11C-acetate in tumor cells is related to the highly active lipid metabolism in the cell membrane associated with tumor growth. 11C-acetate is channeled into the tricarboxylic acid cycle via acetyl coenzyme A and then incorporated via phosphatidylcholine into the cell membrane's phopholipids. Possible biochemical paths of acetate incorporation or accumulation include (a) entering the Krebs cycle from acetyl coenzyme A (acetyl CoA) or as an intermediate metabolite, (b) esterification to form acetyl CoA as a major precursor in ß-oxidation for fatty acid synthesis, (c) combining with glycine in heme synthesis, and (d) through citrate for cholesterol synthesis. Of all of these possible metabolic pathways, participation in free fatty acid (lipid) synthesis is believed to be the dominant method of incorporation in tumors.
The clinical data on the role of 11C-acetate PET in human tumors is being accumulated. Most clinical studies have investigated the role of 11C-acetate PET in detection of prostate cancer. 11C-acetate PET was found valuable in the detection of recurrent prostate cancer, both in the prostate bed, lymph nodes and distant metastases. The main advantage of 11C-acetate is that it does not show physiological accumulation in the urinary bladder as is the case with 18F -FDG and therefore may be appropriate for the detection of active pelvic disease.
Comparing the uptake of 18F-FDG and of 11C-acetate in patients with lung carcinoma, the latter was found superior in the identification of a bronchiolo-alveolar carcinoma which often show no intense FDG uptake.
In the case of hepatic masses, well-differentiated HCC tumors were detect by 11C-acetate while poorly differentiated types were detected by 18F-FDG.
These data suggest that 11C-acetate PET may be valuable in the detection of well-differentiation slow growing tumors and may have a complementary role to the routinely used 18F-FDG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –100 patients with newly diagnosed tumors, which are often non-FDG avid or show only low intensity uptake: Soft tissue sarcomas, well-differentiated thyroid cancer, well-differentiated and bronchoalveolar lung cancer, indolent lymphomas, neuroendocrine tumors, GIST, uterine malignancies, mucin-producing cancer, teratoma, hepatoma, HCC and lobular breast carcinoma. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with newly diagnosed tumors, which are often non-FDG avid or show only low intensity uptake: Soft tissue sarcomas, well-differentiated thyroid cancer, well-differentiated and bronchoalveolar lung cancer, indolent lymphomas, neuroendocrine tumors, GIST, uterine malignancies, mucin-producing cancer, teratoma, hepatoma, HCC and lobular breast carcinoma.
Key inclusion criteria (14 listed)
- patients with newly diagnosed tumors, which are often non-FDG avid or show only low intensity uptake:
- Patients over the age of 18
Key exclusion criteria (3 listed)
- patients under the age of 18 years
- pregnant and lactating women
- claustrophobic patients
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
Uptake of C11-Acetate and F18-FDG in tumor will be measured in SUV PET units
Time frame: At completion of acuisition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2008.
Related trials for Soft Tissue Sarcomas
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
RecruitingPhase 2
Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma
Soft Tissue Sarcoma
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.
Einat Even-Sapir, MD, PhD principal investigator
Tel-Aviv Sourasky Medical Center
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 Soft Tissue Sarcomas and Thyroid 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 14 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 2 Jun 2008. 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 Einat Even-Sapir, MD, PhD (972-3-697-3536, evensap@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of C11-Acetate and F18-FDG in tumor will be measured in SUV PET units (time frame: At completion of acuisition). 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 2 Jun 2008.