PheochromocytomaPhase 1NCT00004847
Diagnosis of Pheochromocytoma
A Phase 1 study testing ([18F]-DOPA) and ([18F]-6F-DA) in people with Pheochromocytoma and Endocrine Disease, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
The goal of this study is to develop better methods of diagnosis, localization, and treatment for pheochromocytomas. These tumors, which usually arise from the adrenal glands, are often difficult to detect with current methods. Pheochromocytomas release chemicals called catecholamines, causing high blood pressure. Read more about this study
- Who is it for?
- Ages 3 to 120 years
- Conditions the study is for
- Pheochromocytoma, Endocrine Disease, Endocrine Diseases
- What is being tested?
- ([18F]-DOPA) and ([18F]-6F-DA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2000to 30 Nov 2048
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 3 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients are eligible for inclusion in this study if they are adults or children of age 3 years old and up with known, sporadic or familial PHEO/PGL, on the basis of one or more of the following:
- High levels of blood or urinary catecholamines, metanephrines, methoxytyramine or chromogranin A.
- Highly suspected presence of PHEO/PGL based on imaging studies, even with normal biochemistry.
- Personal or family history of PHEO/PGL or genetic pathogenic variants known to predispose individuals to develop PHEO/PGL.
- Signed informed consent is required. The informed consent may be signed by the patient, parent/guardian in pediatric patients or legally authorized representative (LAR) in adults who lack-decision making capacity to consent to research participation.
- Patients must have an outside general practitioner or endocrinologist. Patients with metastatic disease must also have an outside oncologist.
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- Family Members of Patients Arm (Linkage Analysis)
- Participants are eligible for inclusion in this study arm if they are:
- Adult family members of patients enrolled in this study;
- The index family member in this study has a suspected hereditary PHEO/PGL based on previous genetic testing and other suspicious hereditory patterns such as family history of multiple individuals with PHEO/PGL; early age of disease onset; multiplicity of primary tumors; recurrence, etc. and
- Signed informed consent form is required
- Children over 10 years old with very high suspicion of sporadic or familial PHEO/PGL based on at least one of the following:
- The presence of new onset of symptoms typical of PHEO/PGL such as hypertension or hypertensive episodes, sweating, headaches, pallor, palpitations, drug resistant hypertension, etc.
- Family history of PHEO/PGL or genetic pathogenic variants known to predispose individuals to develop these tumors.
- The presence of a tumor on conventional imaging including ultrasound, CT and/or MRI or [123I]-MIBG or PET imaging not limited to [18F]-FDG.
- Children must give informed assent and be willing to return to the NIH for follow-up.
Who cannot join
- Potential patients will be excluded on the basis of one or more of the following:
- Pregnant or breastfeeding women
- Severe cardiac dysfunction
- Currently on dialysis
- A pregnancy test is performed in women of childbearing age (up to age 55) as a screening after consenting. If a patient is found to have a positive pregnancy test, her participation in this protocol will be terminated. The patient can enroll or re-enroll in the protocol when she is no longer pregnant or breastfeeding.
- In-person participating patients who are not willing to return to the NIH (e.g., after surgery or an initial evaluation) for more than 2 years may be removed from the protocol.
Show all 16Show fewer
- SPECIFIC INCLUSION/EXCLUSION CRITERIA FOR IMAGING STUDIES WITHIN OUR PROTOCOL:
- In adult patients (Excludes Linkage Analysis Arm)
- Imaging studies are not done in patients that have the following exclusion criteria:
- Inability to lie still for the entire imaging time (e.g., cough, severe arthritis, etc.).
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (e.g., severe claustrophobia, radiation phobia, etc.)
- Any additional medical conditions, serious illness, or other extenuating circumstance that, in the opinion of the Principal Investigator, may significantly interfere with study compliance.
- In pediatric patients:
- Children of less than 10 years of age.
- Children with impaired mental capacity that precludes informed assent.
- Inability to lie still for the entire imaging time (e.g., cough, turbulent children, severe claustrophobia, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Diagnosis, Pathophysiology, and Molecular Biology of Pheochromocytoma and Paraganglioma
The goal of this study is to develop better methods of diagnosis, localization, and treatment for pheochromocytomas. These tumors, which usually arise from the adrenal glands, are often difficult to detect with current methods. Pheochromocytomas release chemicals called catecholamines, causing high blood pressure. Undetected, the tumors can lead to severe medical consequences, including stroke, heart attack and sudden death, in situations that would normally pose little or no risk, such as surgery, general anesthesia or childbirth.
Patients with pheochromocytoma may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. Study participants will undergo blood, urine, and imaging tests, described below, to detect pheochromocytoma. If a tumor is found, the patient will be offered surgery. If surgery is not feasible (for example, if there are multiple tumors that cannot be removed), evaluations will continue in follow-up visits. If the tumor cannot be found, the patient will be offered medical treatment and efforts to detect the tumor will continue. Main diagnostic and research tests may include the following:
- Blood tests - mainly measurements of plasma or urine catecholamines and metanephrines as well as methoxytyramine. If necessary the clonidine suppression test can be carried out.
- Standard imaging tests - Non-investigational imaging tests include computed tomography (CT), magnetic resonance imaging (MRI), sonography, and 123I-MIBG scintigraphy and FDG (positron emission tomography) PET/CT. These scans may be done before and/or after surgical removal of pheochromocytoma.
- Research PET scanning is done using an injection of radioactive compounds. Patients may undergo 18F-FDOPA, 18F-DA, as well as 68Ga-DOTATATE PET/CT . Each scan takes up to about 2 hours.
- Genetic testing - A small blood sample is collected for DNA analysis and other analyses.
Read the detailed description
Pheochromocytomas (PHEOs) and paragangliomas (PGLs) are rare and clinically important chromaffin cell tumors that typically arise from the adrenal gland or from extra-adrenal paraganglia, respectively. The clinical features and consequences of PHEO/PGL result from the release of catecholamines (norepinephrine and/or epinephrine). An undetected PHEO/PGL poses a hazard to patients undergoing surgery, childbirth, or general anesthesia, due to the potential for excess catecholamine secretion, which can result in significant, often catastrophic outcomes. Diagnosing and localizing a PHEO/PGL can be challenging. Plasma and urinary catecholamines as well as their metabolites and radio-iodinated metaiodobenzylguanidine (MIBG) scanning can yield false-positive/negative results in patients harboring the tumor. Computed tomography (CT) and magnetic resonance imaging (MRI) lack sufficient specificity. The molecular mechanisms by which genotypic changes predispose to the development of PHEO/PGL remain unknown - even in patients with identified pathogenic variants. Moreover, in patients with hereditary predispositions, PHEOs/PGLs differ in terms of their growth, malignant potential, catecholamine phenotype, responses to standard screening tests, various imaging modalities and therefore subsequently, different therapeutic options. This protocol focuses on developmental, molecular, genetic, epigenetic, proteomic, metabolomics, immunologic and other types of studies to investigate the bases for predisposition to develop PHEOs/PGLs and for expression of different neurochemical and other phenotypes and malignant potentials including therapeutic responses. Furthermore, this protocol will also use new imaging approaches, for example [18F]-6F-dopamine ([18F]-6F-DA), and [18F]-L-3,4-dihydroxyphenylalanine ([18F]-FDOPA) positron emission tomography (PET)/CT, as well as dynamic contrast-enhanced MRI.
- Conditions
- Pheochromocytoma, Endocrine Disease, Endocrine Diseases
- Being tested
- ([18F]-DOPA), ([18F]-6F-DA)
- Keywords
- Genetics, Metanephrines, PET, Catecholamines
- Medical subject headings
- Pheochromocytoma, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
([18F]-DOPA)Drug
is L 3, 4 dihydroxyphenylalanine (L-DOPA) labeled with the radioactive isotope 18F. In general, PPGLs belong to the group of neuroendocrine tumors. This heterogeneous group of tumors takes up amino acids, transforms them into biogenic amines (dopamine and serotonin) by decarboxylation and stores the amines in vesicles. L DOPA is a precursor of catecholamines (dopamine, norepinephrine and epinephrine). Epinephrine conversion to dopamine is catalyzed by the aromatic amino acid decarboxylase. According to previous and current studies, [18F]-DOPA PET is highly sensitive and specific for detection of PHEO/PGL67-69. However, there are only a few reports in the literature using [18F]-DOPA as a PET agent and particularly for patients with metastatic PPGLs. PET imaging will be done together with either a CT, an MRI or both modalities.
([18F]-6F-DA)Drug
is an imaging agent developed at the NIH, that may improve specificity and sensitivity in the localization of PPGLs. [18F]-6F-DA enters cells via the membrane norepinephrine transporter. Once inside cells, [18F]-6F-DA is translocated via the vesicular monoamine transporter into storage vesicles, where the radioactivity is concentrated. After injection of [18F]-6F-DA, the much faster disappearance of [18F]-6F-DA-derived radioactivity from the bloodstream and non-neuronal cells than from chromaffin cells should enable rapid visualization of PPGLs by PET scanning.
| Study group | Role | What they receive |
|---|---|---|
| Adults or children with suspected PHEO/PGL | Experimental | Patients are adults or children of any age with known, sporadic or familial PHEO/PGL Receives: Drug: ([18F]-DOPA); Drug: ([18F]-6F-DA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study specific genotypes, biochemical and imaging phenotypes of patients with various pheochromocytomas and paragangliomas.To stuty potential treatment options for metastatic pheochromocytoma and paraganglioma using cell cultures, cell ...
To study specific genotypes, biochemical and imaging phenotypes of patients with various pheochromocytomas and paragangliomas.To stuty potential treatment options for metastatic pheochromocytoma and paraganglioma using cell cultures, cell lines, animal
Measured: Baseline
Secondary outcomes (1)
To educate health care professionals and patients about pheochromocytoma and paraganglioma
To educate health care professionals and patients about pheochromocytoma and paraganglioma
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2000 (estimated)
- Study start22 Mar 2000
- Primary completion30 Nov 2048 (estimated)
- Study completion30 Nov 2048 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PheochromocytomaStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Catherine M Gordon, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004847
- Sponsor's protocol ID
- 000093
- Other IDs
- 00-CH-0093
- Status last verified
- 29 Jul 2026
- First submitted
- 2 Mar 2000
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jha A, Patel M, Carrasquillo JA, Ling A, Millo C, Saboury B, Chen CC, Wakim P, Gonzales MK, Meuter L, Knue M, Talvacchio S, Herscovitch P, Rivero JD, Chen AP, Nilubol N, Taieb D, Lin FI, Civelek AC, Pacak K. Sporadic Primary Pheochromocytoma: A Prospective Intraindividual Comparison of Six Imaging Tests (CT, MRI, and PET/CT Using 68Ga-DOTATATE, FDG, 18F-FDOPA, and 18F-FDA). AJR Am J Roentgenol. 2022 Feb;218(2):342-350. doi: 10.2214/AJR.21.26071. Epub 2021 Aug 25.
PubMed 34431366Wolf KI, Jha A, van Berkel A, Wild D, Janssen I, Millo CM, Janssen MJR, Gonzales MK, Timmers HJKM, Pacak K. Eruption of Metastatic Paraganglioma After Successful Therapy with 177Lu/90Y-DOTATOC and 177Lu-DOTATATE. Nucl Med Mol Imaging. 2019 Jun;53(3):223-230. doi: 10.1007/s13139-019-00579-w. Epub 2019 Feb 22.
PubMed 31231443Abdul Sater Z, Jha A, Mandl A, Mangelen SK, Carrasquillo JA, Ling A, Gonzales MK, Lopes Abath Neto O, Miettinen M, Adams KT, Nockel P, El Lakis M, Pacak K. Gallbladder Paraganglioma Associated with SDHD Mutation: a Potential Pitfall on 18F-FDOPA PET Imaging. Nucl Med Mol Imaging. 2019 Apr;53(2):144-147. doi: 10.1007/s13139-018-0558-1. Epub 2019 Feb 19.
PubMed 31057686Taieb D, Jha A, Guerin C, Pang Y, Adams KT, Chen CC, Romanet P, Roche P, Essamet W, Ling A, Quezado MM, Castinetti F, Sebag F, Pacak K. 18F-FDOPA PET/CT Imaging of MAX-Related Pheochromocytoma. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1574-1582. doi: 10.1210/jc.2017-02324.
PubMed 29534198
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis, Pathophysiology, and Molecular Biology of Pheochromocytoma and Paraganglioma
- ClinicalTrials.gov ID
- NCT00004847
- Acronym / sponsor ID
- 000093
- Conditions
- Pheochromocytoma, Endocrine Disease, Endocrine Diseases
- Keywords
- Genetics, Metanephrines, PET, Catecholamines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 22 Mar 2000 (actual)
- Primary completion
- 30 Nov 2048 (estimated)
- Study completion
- 30 Nov 2048 (estimated)
- First posted
- 3 Mar 2000 (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.
The goal of this study is to develop better methods of diagnosis, localization, and treatment for pheochromocytomas. These tumors, which usually arise from the adrenal glands, are often difficult to detect with current methods. Pheochromocytomas release chemicals called catecholamines, causing high blood pressure. Undetected, the tumors can lead to severe medical consequences, including stroke, heart attack and sudden death, in situations that would normally pose little or no risk, such as surgery, general anesthesia or childbirth.
Patients with pheochromocytoma may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. Study participants will undergo blood, urine, and imaging tests, described below, to detect pheochromocytoma. If a tumor is found, the patient will be offered surgery. If surgery is not feasible (for example, if there are multiple tumors that cannot be removed), evaluations will continue in follow-up visits. If the tumor cannot be found, the patient will be offered medical treatment and efforts to detect the tumor will continue. Main diagnostic and research tests may include the following:
- Blood tests - mainly measurements of plasma or urine catecholamines and metanephrines as well as methoxytyramine. If necessary the clonidine suppression test can be carried out.
- Standard imaging tests - Non-investigational imaging tests include computed tomography (CT), magnetic resonance imaging (MRI), sonography, and 123I-MIBG scintigraphy and FDG (positron emission tomography) PET/CT. These scans may be done before and/or after surgical removal of pheochromocytoma.
- Research PET scanning is done using an injection of radioactive compounds. Patients may undergo 18F-FDOPA, 18F-DA, as well as 68Ga-DOTATATE PET/CT . Each scan takes up to about 2 hours.
- Genetic testing - A small blood sample is collected for DNA analysis and other analyses.
Detailed description
Pheochromocytomas (PHEOs) and paragangliomas (PGLs) are rare and clinically important chromaffin cell tumors that typically arise from the adrenal gland or from extra-adrenal paraganglia, respectively. The clinical features and consequences of PHEO/PGL result from the release of catecholamines (norepinephrine and/or epinephrine). An undetected PHEO/PGL poses a hazard to patients undergoing surgery, childbirth, or general anesthesia, due to the potential for excess catecholamine secretion, which can result in significant, often catastrophic outcomes. Diagnosing and localizing a PHEO/PGL can be challenging. Plasma and urinary catecholamines as well as their metabolites and radio-iodinated metaiodobenzylguanidine (MIBG) scanning can yield false-positive/negative results in patients harboring the tumor. Computed tomography (CT) and magnetic resonance imaging (MRI) lack sufficient specificity. The molecular mechanisms by which genotypic changes predispose to the development of PHEO/PGL remain unknown - even in patients with identified pathogenic variants. Moreover, in patients with hereditary predispositions, PHEOs/PGLs differ in terms of their growth, malignant potential, catecholamine phenotype, responses to standard screening tests, various imaging modalities and therefore subsequently, different therapeutic options. This protocol focuses on developmental, molecular, genetic, epigenetic, proteomic, metabolomics, immunologic and other types of studies to investigate the bases for predisposition to develop PHEOs/PGLs and for expression of different neurochemical and other phenotypes and malignant potentials including therapeutic responses. Furthermore, this protocol will also use new imaging approaches, for example [18F]-6F-dopamine ([18F]-6F-DA), and [18F]-L-3,4-dihydroxyphenylalanine ([18F]-FDOPA) positron emission tomography (PET)/CT, as well as dynamic contrast-enhanced MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults or children with suspected PHEO/PGL | Experimental | Drug: ([18F]-DOPA), Drug: ([18F]-6F-DA)Patients are adults or children of any age with known, sporadic or familial PHEO/PGL |
Who may qualify
- Ages
- 3 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Patients are eligible for inclusion in this study if they are adults or children of age 3 years old and up with known, sporadic or familial PHEO/PGL, on the basis of one or more of the following:
- High levels of blood or urinary catecholamines, metanephrines, methoxytyramine or chromogranin A.
- Highly suspected presence of PHEO/PGL based on imaging studies, even with normal biochemistry.
- Personal or family history of PHEO/PGL or genetic pathogenic variants known to predispose individuals to develop PHEO/PGL.
- Signed informed consent is required. The informed consent may be signed by the patient, parent/guardian in pediatric patients or legally authorized representative (LAR) in adults who lack-decision making capacity to consent to research participation.
Key exclusion criteria (16 listed)
- Pregnant or breastfeeding women
- Severe cardiac dysfunction
- Currently on dialysis
- A pregnancy test is performed in women of childbearing age (up to age 55) as a screening after consenting. If a patient is found to have a positive pregnancy test, her participation in this protocol will be terminated. The patient can enroll or re-enroll in the protocol when she is no longer pregnant or breastfeeding.
- In-person participating patients who are not willing to return to the NIH (e.g., after surgery or an initial evaluation) for more than 2 years may be removed from the protocol.
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 |
|---|---|---|
| ([18F]-DOPA)is L 3, 4 dihydroxyphenylalanine (L-DOPA) labeled with the radioactive isotope 18F. In general, PPGLs belong to the group of neuroendocrine tumors. This heterogeneous group of tumors takes up amino acids, transforms them into biogenic amines (dopamine and serotonin) by decarboxylation and stores the amines in vesicles. L DOPA is a precursor of catecholamines (dopamine, norepinephrine and epinephrine). Epinephrine conversion to dopamine is catalyzed by the aromatic amino acid decarboxylase. According to previous and current studies, [18F]-DOPA PET is highly sensitive and specific for detection of PHEO/PGL67-69. However, there are only a few reports in the literature using [18F]-DOPA as a PET agent and particularly for patients with metastatic PPGLs. PET imaging will be done together with either a CT, an MRI or both modalities. | Drug | Adults or children with suspected PHEO/PGL |
| ([18F]-6F-DA)is an imaging agent developed at the NIH, that may improve specificity and sensitivity in the localization of PPGLs. [18F]-6F-DA enters cells via the membrane norepinephrine transporter. Once inside cells, [18F]-6F-DA is translocated via the vesicular monoamine transporter into storage vesicles, where the radioactivity is concentrated. After injection of [18F]-6F-DA, the much faster disappearance of [18F]-6F-DA-derived radioactivity from the bloodstream and non-neuronal cells than from chromaffin cells should enable rapid visualization of PPGLs by PET scanning. | Drug | Adults or children with suspected PHEO/PGL |
Primary outcome
To study specific genotypes, biochemical and imaging phenotypes of patients with various pheochromocytomas and paragangliomas.To stuty potential treatment options for metastatic pheochromocytoma and paraganglioma using cell cultures, cell ...
Time frame: Baseline
To study specific genotypes, biochemical and imaging phenotypes of patients with various pheochromocytomas and paragangliomas.To stuty potential treatment options for metastatic pheochromocytoma and paraganglioma using cell cultures, cell lines, animal
1 secondary outcome
To educate health care professionals and patients about pheochromocytoma and paraganglioma
Time frame: end of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 34431366Jha A, Patel M, Carrasquillo JA, Ling A, Millo C, Saboury B, Chen CC, Wakim P, Gonzales MK, Meuter L, Knue M, Talvacchio S, Herscovitch P, Rivero JD, Chen AP, Nilubol N, Taieb D, Lin FI, Civelek AC, Pacak K. Sporadic Primary Pheochromocytoma: A Prospective Intraindividual Comparison of Six Imaging Tests (CT, MRI, and PET/CT Using 68Ga-DOTATATE, FDG, 18F-FDOPA, and 18F-FDA). AJR Am J Roentgenol. 2022 Feb;218(2):342-350. doi: 10.2214/AJR.21.26071. Epub 2021 Aug 25.
- Derived from this study: PubMed 31231443Wolf KI, Jha A, van Berkel A, Wild D, Janssen I, Millo CM, Janssen MJR, Gonzales MK, Timmers HJKM, Pacak K. Eruption of Metastatic Paraganglioma After Successful Therapy with 177Lu/90Y-DOTATOC and 177Lu-DOTATATE. Nucl Med Mol Imaging. 2019 Jun;53(3):223-230. doi: 10.1007/s13139-019-00579-w. Epub 2019 Feb 22.
- Derived from this study: PubMed 31057686Abdul Sater Z, Jha A, Mandl A, Mangelen SK, Carrasquillo JA, Ling A, Gonzales MK, Lopes Abath Neto O, Miettinen M, Adams KT, Nockel P, El Lakis M, Pacak K. Gallbladder Paraganglioma Associated with SDHD Mutation: a Potential Pitfall on 18F-FDOPA PET Imaging. Nucl Med Mol Imaging. 2019 Apr;53(2):144-147. doi: 10.1007/s13139-018-0558-1. Epub 2019 Feb 19.
- Derived from this study: PubMed 29534198Taieb D, Jha A, Guerin C, Pang Y, Adams KT, Chen CC, Romanet P, Roche P, Essamet W, Ling A, Quezado MM, Castinetti F, Sebag F, Pacak K. 18F-FDOPA PET/CT Imaging of MAX-Related Pheochromocytoma. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1574-1582. doi: 10.1210/jc.2017-02324.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Catherine M Gordon, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ([18F]-DOPA) and ([18F]-6F-DA) in people with Pheochromocytoma and Endocrine Disease, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 16 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberta Derkyi, C.R.N.P. ((301) 827-3355, alberta.derkyi@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study specific genotypes, biochemical and imaging phenotypes of patients with various pheochromocytomas and paragangliomas.To stuty potential treatment options for metastatic pheochromocytoma and paraganglioma using cell cultures, cell ... (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004847, which also lists 4 linked publications.
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 Oct 2026.