GliomaEarly Phase 1NCT06412952
68Ga-NOTA-RM26 PET/CT in Glioma Patients
A Early Phase 1 study testing 68Ga-RM26 in people with Glioma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The aim of this study was to investigate the value of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR) PET tracer, in the diagnosis of high WHO grade glioma and prediction the grade of glioma using positron-emission tomography/computed tomography (PET/CT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioma
- What is being tested?
- 68Ga-RM26
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 May 2024
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected or confirmed untreated glioma patients
- signed written consent.
Who cannot join
- pregnancy
- breastfeeding
- known allergy against Pentixafor
- any medical condition that in the opinion of the investigator,may
- significantly interfere with study compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Science & Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhaohui Zhu, MD, +8619800370331, pumch_jacobwong@163.com
About this study
The aim of this study was to investigate the value of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR) PET tracer, in the diagnosis of high WHO grade glioma and prediction the grade of glioma using positron-emission tomography/computed tomography (PET/CT).
Read the detailed description
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label brain PET/ CT study was designed to assess its clinical diagnostic value in patients with glioma.
- Conditions
- Glioma
- Being tested
- 68Ga-RM26
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-RM26Drug
Also called 68Ga-GRPR antagonist
Intravenous injection of one dosage of 74-185 MBq(2-5 mCi) 68Ga-RM26. Tracer doses of 68Ga- RM26 will be used to image lesions of glioma by PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-RM26, PET/CT | Experimental | Inject 68Ga-Pentixafor and then perform PET/CT scan. Receives: Drug: 68Ga-RM26 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
SUVmax of focal lesions are measured on 68Ga-RM26 PET/CT.
Measured: through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Oct 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412952
- Sponsor's protocol ID
- PUMCH-68Ga-RM26 in Glioma
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Y, Wang R, Chen J, Zhu Z, Wang Y, Ma W. 68Ga-NOTA-RM26 PET/CT in the evaluation of glioma: a pilot prospective study. EJNMMI Res. 2025 Jan 17;15(1):6. doi: 10.1186/s13550-025-01198-7.
PubMed 39821814Wang R, Li Y, Li Z, Wang J, Li L, Xiang J, Jia C, Peng X, Wang Y, Ma W, Wang L, Jia W, Chen X, Li D, Zhu Z, Zhang J. Gastrin-Releasing Peptide Receptor Targeting PET/CT With 68 Ga-NOTA-RM26 in the Assessment of Glioma and Combined Multiregional Biopsies. Clin Nucl Med. 2025 Apr 1;50(4):316-323. doi: 10.1097/RLU.0000000000005651. Epub 2025 Jan 14.
PubMed 39806560
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-NOTA-RM26 PET/CT in Glioma Patients
- ClinicalTrials.gov ID
- NCT06412952
- Acronym / sponsor ID
- PUMCH-68Ga-RM26 in Glioma
- Conditions
- Glioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 14 May 2024 (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 this study was to investigate the value of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR) PET tracer, in the diagnosis of high WHO grade glioma and prediction the grade of glioma using positron-emission tomography/computed tomography (PET/CT).
Detailed description
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label brain PET/ CT study was designed to assess its clinical diagnostic value in patients with glioma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-RM26, PET/CT | Experimental | Drug: 68Ga-RM26Inject 68Ga-Pentixafor and then perform PET/CT scan. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suspected or confirmed untreated glioma patients
- signed written consent.
Key exclusion criteria (5 listed)
- pregnancy
- breastfeeding
- known allergy against Pentixafor
- any medical condition that in the opinion of the investigator,may
- significantly interfere with study compliance
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-RM26Also: 68Ga-GRPR antagonistIntravenous injection of one dosage of 74-185 MBq(2-5 mCi) 68Ga-RM26. Tracer doses of 68Ga- RM26 will be used to image lesions of glioma by PET/CT. | Drug | 68Ga-RM26, PET/CT |
Primary outcome
SUVmax
Time frame: through study completion, an average of 1.5 years
SUVmax of focal lesions are measured on 68Ga-RM26 PET/CT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 39821814Li Y, Wang R, Chen J, Zhu Z, Wang Y, Ma W. 68Ga-NOTA-RM26 PET/CT in the evaluation of glioma: a pilot prospective study. EJNMMI Res. 2025 Jan 17;15(1):6. doi: 10.1186/s13550-025-01198-7.
- Derived from this study: PubMed 39806560Wang R, Li Y, Li Z, Wang J, Li L, Xiang J, Jia C, Peng X, Wang Y, Ma W, Wang L, Jia W, Chen X, Li D, Zhu Z, Zhang J. Gastrin-Releasing Peptide Receptor Targeting PET/CT With 68 Ga-NOTA-RM26 in the Assessment of Glioma and Combined Multiregional Biopsies. Clin Nucl Med. 2025 Apr 1;50(4):316-323. doi: 10.1097/RLU.0000000000005651. Epub 2025 Jan 14.
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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.
Zhaohui Zhu study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-RM26 in people with Glioma, run by Peking Union Medical College Hospital at 1 site in China.
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 5 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 14 May 2024. 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 China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhaohui Zhu (+8613611093752, 13611093752@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (time frame: through study completion, an average of 1.5 years). 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 NCT06412952, which also lists 2 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 14 May 2024.